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Article 16 Article 6 Article 23 Article 8 Article 4

S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Skip to content Disclaimer Feedback Helpdesk Gaeilge Lé

Article 16(5) of the Directive of the Directive of 1991; "aircraft" includes hovercraft;.

"authorised officer" means an officer of the Minister appointed in writing by the Minister to be an authorised officer for the purpose of these Regulations; 10O.J. No. L228/68, 17/8/

11 O.J. No. L110/20, 4/5/
"the Commission" means the Commission of the European Communities; "the competent authority" for the purposes of these Regulations and Commission Regulation No. 3600 of 11 December 1992 is the Pesticide Control Service of the Department of Agriculture, Food and Forestry; "controlled product" means a product specified by the Minister as such through Orders made pursuant to Regulation 28; "designated chemist" means an officer of the Minister holding the position of a chemist authorized in writing by the Minister for the purposes of these Regulations; "the Directive of 1991" means Council Directive No. 91/414/EEC of 15 July 19911; "the Directive of 1967" means Council Directive 67/548/EEC of 27 June, 19678; "the Directive of 1978" means Council Directive No. 78/631/EEC of 26 June, 19785, as amended and adapted; "the Directive of 1992" means Council Directive No. 92/32/EEC of 30 April, 19929, as amended and adapted; "good agricultural practice" in the use of a plant protection product, means safe use of the plant protection product under actual conditions necessary for its effective action,

an authorization granted pursuant to these Regulations, encompassing a range of levels of application up to the highest level of use for which an authorization has been granted, applied in a manner which leaves a residue which is the smallest practicable; safe use, in relation to good agricultural practice, means taking into account public and occupational health and environmental considerations; actual conditions of use include any stage in the production, storage, transport and distribution of plants and plant products; "good plant protection practice" in the use of plant protection products, means their responsible use

principles defining such use, as set out in the Second Schedule hereto, taking account of the range of authorized products available, the spectrum of harmful organisms occurring, the production, storage, transport and distribution conditions for plants and plant products and alternative means of plant protection available; 1 O.J. No. L230/1 19/8/1991 8 O.J. No. L196/1 16/8/1967 5 O.J. No. L206/13 29/7/1978 9 O.J. No. L154/1 5/6/1992 "Member State" means a Member State of European Communities; "the Minister" means the Minister for Agriculture, Food and Forestry; "officially recognized testing facilities and organizations" for the purposes of these Regulations, means testing facilities and organizations which carry out experiments, studies, tests and analyses

these Regulations; "officially recognized tests and analyses" for the purposes of these Regulations, means experiments, studies, tests and analyses carried out

methodologies and to a standard specified from time to time by the competent authority and issued as guideline documentation; "the Regulations of 1994" means the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 ( S.I. No. 138 of 1994 ); "the State Chemist" means the Head of the State Laboratory or a member of the staff of the State Laboratory holding the position of a chemist authorized by the State Chemist in writing to perform functions assigned to the State Chemist under Regulation 34; "trials permit" means a permit granted under Regulation 26.

(2)In these Regulations, unless otherwise indicated— ( a ) a reference to a Regulation is a reference to a Regulation of these Regulations, ( b ) a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision in which the reference occurs, ( c ) a reference to a Schedule is a reference to a Schedule to these Regulations.

(3)A word or expression that is used in the Directive of 1991 or in any other Council or Commission Directive of the European Communities mentioned in these Regulations has, unless the contrary intention appears, the meaning in these Regulations that it has in the Directive concerned. 3 Application 3. These Regulations apply to any plant protection product which is a plant protection product for the purposes of the Directive of 1991. 4 .. 4.

(1)Subject to paragraphs

(2)and

(3), the placing on the market and use of a plant protection product in the form in which it is supplied to the user and intended for use as such is hereby prohibited unless the requirements of these Regulations regarding its authorization are complied with.

(2)The placing on the market of a plant protection product in the form in which it is supplied to the user and intended for use as such is hereby prohibited if— ( a ) the net quantity in any container of such a plant protection product is less than the quantity stated there on in the manner specified in Article 16

(1)(d) of the Directive of 1991, or ( b ) the fastenings or containers used to package the plant protection product have been tampered with.

(3)The placing on the market of a plant protection product in the form in which it is supplied to the user and intended for use as such is hereby prohibited unless the annual fees as provided for in Regulation 36

(4)have been paid by the dates specified

the provisions of that Regulation.

(4)These Regulations shall not apply to— ( a ) the production, storage or movement of a plant protection product which has not been authorized, where it is intended for use in another Member State and where— (i) the product is authorized in the other Member State, and (ii) the provisions of Regulation 30 are complied with.

(5)Regulations 6, 7, 8, 12, 13, 15, 16 and 18 shall not apply to plant protection products authorized for trials purposes

Regulations 25 and 26. 5 Exemptions from Certain Provisions of the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 ( S.I. No 138 of 1994 ) and from certain provisions of these Regulations 5.

(1)Plant protection products which are pesticides referred to in paragraph

(1)(a) of Regulation 3 of the Regulations of 1994, which are classified

Regulation 5 of those Regulations— ( a ) are hereby exempted from the provisions of Regulation 6 paragraphs

(2)(

a)and (
b)and Regulation 18 of those Regulations, and ( b ) are hereby deemed to comply with the provisions of Regulation 6 paragraph

(1)and Regulations 7 and 8 of the Regulations of 1994, where they have been authorized

these Regulations.

(2)Plant protection products which are pesticides referred to in paragraph

(1)(a) of Regulation 3 of the Regulations of 1994 and which are on the market before these Regulations come into effect, may continue to be placed on the market for use

the Regulations of 1994, until such time as they are authorized

these Regulations, or are refused such authorization.

(3)Notwithstanding the provisions of Regulations 8, 13 and 18, in the case of a plant protection product which is not on the market before these Regulations come into effect, where the plant protection product is similar to and considered by the competent authority to involve no greater risk for man, animals or for the environment than a plant protection product placed on the market

the provisions of the Regulations of 1994 and— ( a ) the record of the studies conducted and the information, documentation and materials referred to in Regulation 6

(2)(a) of those Regulations, has not yet been approved, or ( b ) at least one active substance contained in the plant protection product is contained in a plant protection product cleared

those Regulations, permission may be granted by the competent authority on approval of an accurate record of a limited number of studies, information, supporting documentation and materials, as specified from time to time by the competent authority, to market and use such a plant protection product, where application is made in the form set out in the Second Schedule, unless in the case of the plant protection product already on the market,

Regulation 10, the periods specified in that Regulation have not yet expired for information referred to in Regulation 8

(3)(a) and (b). 6 Use of Plant Protection Products 6.

(1)The use of a plant protection product other than as specified in paragraph

(2), is hereby prohibited.

(2)Plant protection products shall be used— ( a ) in compliance with the conditions established

Regulations 13, 15, 18 and 19 and specified on the labelling, as appropriate, ( b ) in compliance with the conditions established

Regulation 16, as appropriate, ( c ) in the case of plant protection products on the market before these Regulations come into effect, 1 October 1994 and pending their authorization

these Regulations, in compliance with the conditions specified on the labelling,

the requirements of the Regulations of 1994, ( d )

the Principles of Good Plant Protection Practice as set out in the Third Schedule, and ( e ) where possible,

the principles of integrated control. 7 Marketing of Active Substances 7.

(1)Subject to paragraph

(2), the placing on the market of active substances is hereby prohibited unless— ( a ) they are classified, packaged and labelled

the Directive of 1967, and ( b ) where the active substance was not on the market 2 years after notification of the Directive of 1991, a dossier has been forwarded to the Member States and the Commission,

Article 6of that Directive, with the declaration that the active substance is intended for a use specified in Article 2

(1)of that same Directive.

(2)This Regulation shall not apply to active substances contained in plant protection products intended for use for trials purposes

Regulations 25 and 26. 8 Application for Authorization 8.

(1)Every application for authorization of a plant protection product intended to be placed on the market, shall be made by or on behalf of the person responsible for first placing it on the market. Every applicant for an authorization shall have a business premises in a Member State. Applications shall be in the form set out in Part 1 of the Fourth Schedule.

(2)Applications, which shall be supported with the documentation specified in paragraph

(3)and where relevant, paragraphs

(5)(b) and

(6), shall be in the English language and shall be in the form set out in Part 2 of the Fourth Schedule.

(3)Every application for authorization of a plant protection product, shall be submitted to the competent authority and shall be supported with— ( a ) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III, and ( b ) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II, ( c ) samples of the packaging and models, drafts or samples of labelling and leaflets referred to in Regulations 23 and 24, ( d ) samples of the plant protection product and of each active substance included in it and analytical standards for each such active substance, for impurities and formulants of toxicological or environmental significance, and for transformation products of the active substance included in the residue definition, and ( e ) the relevant fee

Regulation 36.

(4)The tests and analyses conducted for the purposes of compiling dossiers referred to in paragraph

(3)(a), shall be carried out under agricultural, plant health and environmental conditions relevant to use of the plant protection product in question and representative of those prevailing where the product is intended to be used, and shall be officially recognized tests and analyses.

(5)Notwithstanding paragraph

(2), and subject to Regulation 10— ( a ) applicants shall be exempted from supplying the information required under paragraph 3 (b), except for that identifying the active substance, if the active substance is already listed in Annex I, taking into account the conditions of inclusion in Annex I, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the Annex II dossier accompanying the original application, and ( b ) in the case of a plant protection product already authorized in another Member State, at the request of an applicant, who must substantiate the claim to comparability with documentary evidence, applicants shall be exempted from repeating tests and analyses already carried out in connection with the authorization of the product, to the extent that agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned.

(6)Notwithstanding paragraph

(2), and subject to Regulation 10, every application for authorization of a plant protection product

Regulation 13,

(2), taking account of the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the regions concerned, shall be supported with a claim as to the comparability of the regions concerned and shall be supported with documentary evidence to support any such claim. 9 Limiting of Testing involving Vertebrate Species 9.

(1)Notwithstanding the provisions of Regulations 8 and 10, applicants for authorization of plant protection products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority— ( a ) whether the plant protection product for which an application is to be made is the same as a plant protection product for which authorization has been granted, and ( b ) as to the name and address of the holder of the authorization.

(2)Where the competent authority is satisfied on the basis of documentary evidence provided that the prospective applicant intends to apply for authorization on his own behalf and that the other information specified in Regulation 8

(3)is available to him or for use on his behalf, it shall provide the name and address of any holder of a previous relevant authorization and shall at the same time inform that holder of the name and address of the applicant.

(3)The holder of a previous authorization and the applicant shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

(4)Where data is to be submitted with a view to inclusion in Annex I of an active substance already on the market 2 years after notification of the Directive of 1991, the competent authority shall encourage applicants to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals.

(5)Where application is made for the inclusion in Annex I of an active substance already on the market 2 years after notification of the Directive of 1991, applicants shall take all reasonable steps to reach agreement on— ( a ) the sharing of relevant data and information, and ( b ) the submission collectively of all the data and information concerned. 10 Data Protection 10.

(1)Information contained in the dossier referred to in Regulation 8

(3)(

b)shall not be used to the benefit of other applicants unless— ( a ) the applicant has agreed with the first applicant that use may be made of such information and the first applicant has submitted written confirmation of such agreement, or ( b ) 10 years have elapsed from the first inclusion in Annex I of an active substance first placed on the market in the European Communities as a constituent of a plant protection product 2 years after the notification of the Directive of 1991, or ( c ) 10 years have elapsed from the date of first marketing within the territory of the state of an active substance as a constituent of a plant protection product which was on the market 2 years after the notification of the Directive of 1991, and 5 years have elapsed from the date of decision in the case of further information which is generated specifically for and is necessary— (
i)for first inclusion of an active substance in Annex I, or (
ii)to vary the conditions for, or to maintain, the inclusion of an active substance in Annex I.

(2)Notwithstanding the period of 5 years provided for in paragraph

(1), where that period expires before the periods provided for in paragraphs

(1)(b) and

(1)(c) the period of 5 years shall be extended so as to expire on the same date as those periods.

(3)Information contained in the dossier referred to in Regulation 8

(3)(a) shall not be used to the benefit of other applicants unless— ( a ) the applicant has agreed with the first applicant that use may be made of such information and the first applicant has submitted written confirmation of such agreement, or ( b ) 10 years have elapsed from the first authorization or marketing of the plant protection product in any Member State, where authorization follows the inclusion in Annex I of any active substance contained in the product, or ( c ) 10 years have elapsed from the date of first marketing within the territory of the state of a plant protection product where such marketing precedes inclusion in Annex I of any active substance contained in the product.

(4)The provisions of subparagraphs

(1)(c),

(2)and

(3)(c) also apply to data and information submitted

the provisions of the Regulations of 1994.

(5)The competent authority shall inform the Commission of each instance in which an application for authorization of a plant protection product is being considered where they consider an active substance to be listed in Annex I, that has been produced by a person or manufacturing process other than those specified in the dossier on the basis of which the active substance was first included in Annex I.

(6)In each instance referred to in paragraph

(5), the competent authority shall transmit to the Commission all data regarding the identity and impurities of the active substance concerned. 11 Confidentiality 11.

(1)An applicant for authorization of a plant protection product, who claims that certain information submitted

Regulation 8, includes information involving industrial and commercial secrets, may make application for such information to be treated as confidential. Any such application shall identify the information concerned and shall for each such item of information include a statement justifying it being treated as confidential.

(2)Subject to paragraphs

(3)and

(4)and without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment12, the competent authority shall ensure that information referred to in paragraph

(1)is treated as confidential where it is accepted by the competent authority that such treatment is warranted.

(3)Confidentiality shall not apply to— ( a ) the names and content of the active substance or substances and the name of the plant protection product, ( b ) the name of other substances which are regarded as dangerous under Directives 67/548/EEC and 78/631/EEC, ( c ) physico-chemical data concerning the active substance and plant protection product, ( d ) any ways of rendering the active substance or plant protection product harmless, 12 O.J. No. L158/56 23/6/1990 ( e ) a summary of the results of the tests to establish the substance's or product's efficacy and harmlessness to humans, animals, plants and the environment, ( f ) recommended methods and precautions to reduce handling, storage, transport, fire or other hazards, ( g ) methods of analysis referred to in Article 4

(1)(

c)and (
d)and 5

(1)of the Directive of 1991, ( h ) methods of disposal of the product and of its packaging, ( i ) decontamination procedures to be followed in the case of accidental spillage or leakage, or ( j ) first aid and medical treatment to be given in the case of injury to persons.

(4)Where applicants subsequently disclose previously confidential information, they shall inform the competent authority accordingly. 12 Consideration of Applications for Authorization of Plant Protection Products and for Inclusion of Active Substances in Annex I 12.

(1)The competent authority shall consider each application received for the authorization of a plant protection product and provided that it has the necessary scientific and technical resources at its disposal, shall inform the applicant within a reasonable period, of its decision as to whether the application has been granted or refused.

(2)In the case of applications involving one or more active substances not on the market in the European Communities as a constituent of a plant protection product 2 years after notification of the Directive of 1991, and not subsequently included in Annex I, the competent authority shall, without undue delay, assess the information provided to determine if the requirements specified in Regulation 8

(3)have been satisfied. For each such application believed to satisfy the requirements of Annex II, the competent authority shall require the applicant to forward the dossier to the competent authorities of the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance.

(3)Where

paragraph

(2), applicants are required to forward a dossier believed to satisfy the requirements of Annex II and a dossier complying with Annex III on at least one preparation containing the active substance, the competent authority shall,

Article 6

.3, request the Commission to establish whether the dossiers satisfy the requirements of Annex II and Annex III,

the procedure provided for in that Article. 13 Granting of Authorizations 13.

(1)The competent authority shall not authorize the placing on the market and use of any plant protection product unless— ( a ) its active substances are listed in Annex I and any conditions laid down therein are fulfilled, ( b ) following application of the uniform principles as contained in Annex VI, the requirements of Article 4

(1)(b), (c), (

d)and (
e)of the Directive of 1991 are satisfied, ( c ) maximum residue levels in the agricultural products referred to in the authorization have been provisionally established, and notified to the Commission

Regulation 22, such maximum residue levels, when adopted pursuant to paragraph

(1)of Regulation 28, to remain in force until replaced

the procedures specified in Article 4

(1)(f) of the Directive of 1991, and ( d ) its packaging and labelling satisfy the provisions of Regulations 23 and 24.

(2)Subject to paragraphs

(3)and

(4), in the case of a plant protection product already authorised

the provisions of the Directive of 1991 in another Member State, and where the product contains only active substances included in Annex I, at the request of the applicant, the competent authority, to the extent that Annex VI has been adopted

Article 23

of the Directive of 1991, shall authorize the placing on the market and use of the product, where it has been established that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned.

(3)Restrictions on use, necessary in order to avoid exposure of consumers of treated products to risks of dietary contamination in excess of the acceptable daily intake of the residues concerned, and to take account of differences in dietary patterns, shall where appropriate be attached to authorizations granted

paragraph

(2).

(4)With the agreement of the applicant, authorizations granted

paragraph

(2)shall be subject to changes in the conditions of use in order to render, in the regions concerned, any non-comparable agricultural, plant health or environmental (including climatic) conditions irrelevant for the purpose of comparability.

(5)In granting authorizations

paragraph

(1)or Regulation 15

(2), the competent authority shall attach those conditions and restrictions to each authorization, as are necessary and relevant— ( a ) to ensure compliance with Article 4

(1)(b) of the Directive of 1991, and ( b ) to ensure the maximum residue levels provisionally established

paragraph

(1)(c) and Regulation 28 are not exceeded.

(6)Subject to the provisions of Regulation 36, authorizations granted

this Regulation shall be for fixed periods of 10 years. 14 Refusal to Recognize Comparability 14.

(1)Where the competent authority does not accept that claims as to comparability, with respect to the agricultural, plant health and environmental (including climatic) conditions relevant to use of the product in the regions concerned, made

Regulation 8

(5)(b), are justified, and has required the repetition of one or more tests and analyses, it shall notify the Commission of the grounds on which the repetition of testing or analysis was required.

(2)Where the competent authority does not accept that claims as to comparability, with respect to the agricultural, plant health and environmental (including climatic) conditions relevant to use of the product in the regions concerned, made

Regulation 13

(2), are justified, and has refused to authorize a plant protection product

that provision, it shall notify the Commission of the grounds on which the authorization was refused.

(3)Where a decision different from that of the competent authority is made pursuant to Article 10.3 of the Directive of 1991, the competent authority shall without delay accept the tests and analyses or authorize the placing of the plant protection product on the market, subject in the latter case to any terms which the above decision may set. 15 Authorization for Provisional Periods 15.

(1)Notwithstanding the provisions of Regulation 13

(1)(a), application may be made

Regulation 8 for the authorization for a provisional period of the placing on the market and use of a plant protection product containing an active substance not listed in Annex I and not yet available on the market 2 years after the notification of the Directive of 1991.

(2)The competent authority may grant such an authorization for a period not exceeding three years, provided that— ( a ) following application of Article 6

(2)and

(3)of the Directive of 1991, it is found that the dossier on the active substance satisfies the requirements of Annexes II and III in relation to the projected uses, ( b ) the active substance can satisfy the requirements of Article 5

(1)of the Directive of 1991 and that the plant protection product may be expected to satisfy the requirements of Regulation 13

(1)(b) and (c), and ( c ) its packaging and labelling satisfy the provisions of Regulations 23 and 24.

(3)The competent authority shall immediately inform the other Member States and the Commission of its assessment of each application considered and of the terms of each authorization granted for a provisional period, giving at least the information provided for in Regulation 22

(1).

(4)Notwithstanding the provisions of paragraph

(2), where on expiry of the three-year period, a decision has not been taken concerning the inclusion of an active substance in Annex I, a further period of provisional authorization may be granted of a duration consistent with the period ordered

the final paragraph of Article 8

(1)of the Directive of 1991.

(5)The granting of authorizations for provisional periods shall be subject to the provisions of Regulation 36. 16 Extension of the Field of Application of Authorized Plant Protection Products 16.

(1)Official or scientific bodies involved in agricultural activities or professional agricultural organizations and professional users may request that the field of application of a plant protection product already authorised be extended to purposes other than those covered by the authorization.

(2)Subject to the provisions of paragraph

(4), the competent authority shall grant an extension of the field of application of an authorized plant protection product, when it is in the public interest to do so, where— ( a ) an application for an extension of the field of application of an authorized plant protection product, is made and is in the form set out in Part 1 of the Fifth Schedule, ( b ) documentation and information, as specified in Part 2 and Part 3 of the Fifth Schedule, to support an extension of the field of application has been submitted by the applicant, ( c ) the competent authority has established that the conditions referred to in Article 4

(1)(b)(iii), (

iv)and (
v)of the Directive of 1991, are satisfied, and ( d ) the extension of the field of application relates to a use or uses which is or are minor in nature.

(3)The competent authority shall ensure that users are fully and specifically informed as to instructions for use, by means of an addition to the labelling or, failing that, by means of an official publication.

(4)The granting of an extension of the field of application of an authorized plant protection product shall be subject to the provisions of Regulation 36. Each such extension granted shall expire on the same date as the authorization to which it relates.

(5)The provisions of this Regulation shall also apply to plant protection products which are pesticides referred to in Regulation 3

(1)(a) of the Regulations of 1994, which have not yet been authorized

these Regulations and which are placed on the market

the Regulations of 1994. 17 Information on Potentially Harmful Effects 17.

(1)Those to whom an authorization has been granted and those to whom an extension of the field of application has been granted

Regulation 16, shall immediately notify the competent authority of all new information on the potentially dangerous effects of any plant protection product, or of residues of an active substance, on human or animal health or on ground water, or their potentially dangerous effects on the environment.

(2)The competent authority shall require the parties concerned to immediately notify the information provided

paragraph

(1)to the other Member States and to the Commission. 18 Authorization of Plant Protection Products Containing Active Substances on the Market Prior to 25 July 1993, Pending a Decision concerning their inclusion in Annex I 18.

(1)Subject to the provisions of paragraph

(4)and Regulation 19

(7), during the period to 24 July 2003, applications may be made to the competent authority for authorization of plant protection products

Regulation 8 for products containing active substances not listed in Annex I that are already on the market 2 years after the notification of the Directive of 1991.

(2)Pending the review of such active substances

Article 8

(2)of the Directive of 1991, such applications shall be examined by the competent authority, which shall decide thereon within a reasonable period, provided that it has the necessary scientific and technical resources at its disposal.

(3)In deciding on applications made

paragraph

(1), the competent authority shall not authorize the placing on the market and use of any plant protection product unless— ( a ) following application of the uniform principles as contained in Annex VI, the requirements of Article 4

(1)(b), (c), (

d)and (
e)of the Directive of 1991 are satisfied, ( b ) maximum residue levels in the agricultural products referred to in the authorization have been provisionally established, and notified to the Commission

Regulation 22, such maximum residue levels, when adopted pursuant to 28

(1), to remain in force until replaced

the procedures specified in Article 4

(1)(f) of the Directive of 1991, and ( c ) its packaging and labelling satisfy the provisions of Regulations 23 and 24.

(4)Subject to the provisions of Regulation 36, an authorization granted

this Regulation shall be for a fixed period of 10 years. 19 Renewal, Review, Amendment and Cancellation of Authorizations and Extensions of the field of Application of Authorized Plant Protection Products 19.

(1)Subject to the provisions of paragraph

(12), where an application is made for the renewal of an authorization in the form set out in Part 1 of the Sixth Schedule, and is supported with the documentation specified in Regulation 8

(3)and where relevant, the documentation specified in Regulation 8

(5)(b), the authorization shall be renewed where the competent authority has verified that the requirements of Regulation 13

(1)are still satisfied. Renewal shall be granted for the period necessary for such verification, where an application for such renewal has been made.

(2)Subject to the provisions of paragraph

(12), where an application is made for the renewal of an extension of the field of application of an authorization in the form set out in Part 2 of the Sixth Schedule, and is supported with the documentation specified in Regulation 16

(2)(b), an extension shall be renewed where the competent authority has verified that the requirements of Regulation 16

(2)are still satisfied. Renewal shall be granted for the period necessary for such verification, where an application for such renewal has been made.

(3)An authorization may be reviewed at any time specified by the competent authority, if there are indications that any of the requirements provided for in Regulation 13

(1)are no longer being satisfied. In such a case the competent authority shall require the holder of the authorization concerned, or party to whom an extension of the field of application was granted

Regulation 16, to submit further information necessary for the review at a time to be specified by the competent authority. The authorization shall, where necessary, be extended for the periods necessary to provide such further information and to complete the review.

(4)Where an application is made by the holder of an authorization for its modification in the form set out in Part 3 of the Sixth Schedule and is supported with a statement as to the reasons therefor and with the documentation specified in Regulation 8

(3), subject to the provisions of paragraph

(12), an amendment to the authorization shall be granted where the competent authority has verified that the requirements of Regulation 13

(1), Regulation 15

(2)and Regulation 18

(2), as appropriate, are still satisfied.

(5)Where an application is made by the holder of an authorization for its cancellation in the form set out in Part 4 of the Sixth Schedule and is supported with a statement as to the reasons therefor, the competent authority shall cancel the authorization.

(6)Without prejudice to decisions taken pursuant to Regulation 13

(2), authorizations shall be: ( a ) cancelled if it is established that— (

i)the requirements for obtaining the authorization are not, or are no longer, satisfied, or (
ii)false or misleading particulars were supplied concerning the facts on the basis of which the authorization was granted; or ( b ) modified if it is established that on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified.

(7)Following the evaluation of a dossier as provided for in Article 6

(3)of the Directive of 1991 the competent authority, within 6 months of the completion of the evaluation concerned, shall— ( a ) where it has been decided that the active substance does not satisfy the requirements specified in Article 5

(1)of the Directive of 1991, cancel any authorization granted

Regulations 13 or 15

(2)for plant protection products containing the active substance, and ( b ) where it has been decided to include the active substance in Annex I of the Directive of 1991, modify any authorization granted

Regulations 13 and 15

(2)and modify any extension of the field of application of any authorization granted

Regulation 16, for each plant protection product containing the active substance, such that the conditions and restrictions associated with inclusion of the active substance in Annex I are complied with.

(8)Following the review of an active substance

Article 8

(2)of the Directive of 1991, the competent authority shall— ( a ) within 6 months of the completion of each such review, where a decision is taken not to include an active substance in Annex I, (i) in the case of a pesticide referred to in Regulation 3

(1)(a) of the Regulations of 1994, which is a plant protection product and which contains the active substance, cancel each notification, clearance and permission to market granted

the Regulations of 1994, for the each product concerned, and (ii) cancel each authorization granted

Regulation 18 and each permission granted

Regulation 5

(3), for each plant protection product containing the substance; ( b ) within 6 months of the completion of each such review, where a decision is taken to include an active substance in Annex I, (i) in the case of a pesticide referred to in Regulation 3

(1)(a) of the Regulations of 1994, which is a plant protection product and which contains the active substance, — cancel each relevant notification, clearance and permission to market granted

those Regulations, for each product concerned, where

Regulation 10, information referred to in Regulation 8

(3), may not be used to support its authorization, unless the information concerned is provided

subparagraph (c), — modify each notification, clearance and permission to market granted

those Regulations, for each product concerned, such that the conditions and restrictions associated with inclusion of the active substance in Annex I are complied with, (ii) in the case of an authorization granted

Regulation 18 and a permission granted

Regulation 5

(3), for a plant protection product containing the active substance, — cancel the authorization or permission to market, as appropriate, where

Regulation 10, information referred to in Regulation 8

(3), may not be used to support the authorization or permission, unless the information concerned is provided

subparagraph (c), — modify the authorization or permission to market for each product concerned, such that the conditions and restrictions associated with inclusion of the active substance in Annex I are complied with; and ( c ) where a decision is taken to include an active substance in Annex I, (i) require persons marketing a pesticide referred to in Regulation 3

(1)of the Regulations of 1994, which is a plant protection product and which contains the active substance, to make application for its authorization

these Regulations, at a time specified by the competent authority, (ii) in the case of a permission granted

Regulation 5

(3), for a plant protection product containing the active substance, require persons marketing the product concerned to make application for its authorization

these Regulations, at a time specified by the competent authority, (iii) in cases referred to in subparagraphs (i) and (ii), subject to the provisions of paragraph

(12), examine, and authorize or not each plant protection product concerned

these Regulations, within a period of 2 years following the receipt of a complete application, (

iv)in cases referred to in subparagraphs (
i)and (ii), where complete applications are not received by the dates specified, refuse authorization for each plant protection product concerned, unless — it is established that the necessary supporting documentation is being generated, or — access to such documentation is being negotiated.

(9)Where the competent authority has valid reasons to consider that a plant protection product which it has authorized or is bound to authorize

Regulation 13

(1)or

(2)or Regulation 15

(2), constitutes a risk to human or animal health or the environment, it shall provisionally restrict or prohibit the use and/or sale of that product. In such instances, the competent authority shall immediately inform the Commission and the other Member States of such action and provide reasons for its decision.

(10)Where an authorization is cancelled

this Regulation, the competent authority shall immediately inform the holder of the authorization of the cancellation. Without prejudice to decisions taken and periods provided for in any decision under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances 13, as last amended by Directive 90/533/EEC14, or the consequences of decisions taken pursuant to Article 6

(1)or Article 8

(1)or

(2)of the Directive of 1991, notwithstanding the provisions of this Regulation, or the provisions of Regulations 4, 6 and 31, the competent authority may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length

the reason for the withdrawal.

(11)In the case of a plant protection product for which some or all uses are cancelled or modified pursuant to the provisions of paragraph

(8), notwithstanding the provisions of this Regulation, or of Regulations 4, 6 and 31, an authorised officer acting on behalf of the Minister, may, by a notice in writing given to the owner or person in apparent charge or control, permit the controlled placing on the market or use of existing stocks of the plant protection product, subject to such conditions as he may specify in order to minimize any unacceptable risk to man, animals or the environment that might arise from such use.

(12)The consideration of applications for the renewal of an authorization

paragraph

(1), for the renewal of an extension of the field of application of an authorization

paragraph

(2), for the modification of an authorization

paragraph

(4)and for authorization

paragraph

(8)(c), shall be subject to the provisions of Regulation 36. 13 O.J. No. L33/36 8/2/1979 14 O.J. No. L296/63 27/10/1990

(13)Authorizations granted

these Regulations shall be cancelled where there has been a failure to comply with the provisions of Regulation 36

(4). 20 Emergency Authorizations 20.

(1)Notwithstanding the provisions of Regulations 13, 15 and 18, the competent authority may authorize for a period not exceeding 120 days the placing on the market of plant protection products not complying with the provisions of Regulations 13, 15 or 18 for limited and controlled use if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means.

(2)Where authorizations are granted

paragraph

(1), the competent authority shall immediately inform the other Member States and the Commission of its action. 21 Files on Applications 21.

(1)The competent authority shall ensure that a file is compiled on each application for authorization of a plant protection product

Regulations 13, 15 and 18, and on each application for extension in the field of application of an authorized plant protection product

Regulation 16.

(2)Each file shall contain at least— ( a ) a copy of the application, ( b ) a record of the administrative decisions taken by the competent authority concerning the application, ( c ) a record of the administrative decisions taken by the competent authority concerning the particulars and documentation provided for

Regulation 8

(3), and ( d ) a summary of the particulars and documentation provided for

Regulation 8

(3),

(5)(b) and

(6).

(3)The competent authority shall on request make available to the competent authorities of other Member States and to the Commission the files provided for in paragraph

(1), and shall supply to them on request all information necessary for full comprehension of applications, and shall, where requested, ensure that applicants provide a copy of the technical documentation specified in Regulation 8

(3)(a). 22 Information Exchange 22.

(1)Within a period of one month at the end of each quarter, the competent authority shall inform the competent authorities of the other Member States and the Commission in writing of any plant protection product authorized or for which an authorization has been cancelled,

the provisions of these Regulations, indicating at least— ( a ) the name or business name of the holder of the authorization, ( b ) the trade name of the plant protection product, ( c ) the type of preparation, ( d ) the name and amount of each active substance which it contains, ( e ) the use or uses for which it is or was intended, ( f ) the maximum residue levels provisionally established where they have not already been set by Community rules, ( g ) where relevant, the reasons for cancellation of an authorization, and ( h ) the dossier needed for the evaluation of the maximum residue levels provisionally established.

(2)The competent authority shall draw up an annual list of the plant protection products authorized in its territory and shall communicate that list to the competent authorities of the other Member States and to the Commission. 23 Packaging 23.

(1)The packaging of plant protection products authorized

these Regulations, together with the fastenings and containers used in such packaging and the materials constituting such packaging or fastenings shall comply with the requirements of Article 5

(1)of the Directive of 1978, whether or not they are pesticide preparations which are dangerous for the purposes of the Directive of 1978.

(2)Where the packaging of a plant protection product to which these Regulations apply includes an inner liner, except where the liner is used as a seal to protect rodenticide baits, or is a water soluble sachet contained in a sealed foil sachet, it shall not be detachable from the rest of the packaging unless it itself complies with the requirements of paragraph

(1).

(3)In addition to complying with paragraph

(1)— ( a ) packages containing a plant protection product to which these Regulations apply shall be closed with a distinctive seal in such a way that when the package is opened for the first time the seal is irreparably damaged, and ( b ) containers having a capacity not exceeding three litres shall have childproof fastenings designed

Annex VII where the plant protection product— (

i)is intended for domestic or garden use, and (
ii)is a pesticide preparation which is a dangerous pesticide for the purposes of the Directive of 1978. 24 Labelling 24.

(1)The packaging of plant protection products authorized

these Regulations, or labels attached to packaging, shall comply with the requirements of paragraph

(2)as to labelling.

(2)Subject to the provisions of paragraph

(3), the following information shall be stated clearly and in an indelible form on all packaging which is packaging mentioned in Regulation 23

(1), or on a label on or attached to such packaging in the Irish language or in the English language or in both the Irish and English languages: ( a ) the trade name or designation of the plant protection product; ( b ) the name and address of the holder of the authorization and the authorization number of the plant protection product and, if different, the name and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market; ( c ) the name of each active substance as given in the list contained in Annex I to the Directive of 1967, if not included therein, its ISO common name. If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules; ( d ) the amount of each active substance so contained expressed— (

i)for pesticides which are solids, aerosols, volatile liquids (maximum boiling point 50°C) or viscous liquids (lower limit 1 Pas at 20°C), as a percentage by weight, (
ii)for other liquids, as a percentage by weight and in grams per litre at 20°C, (iii) for gases, as a percentage by volume, and (
iv)for acids, their amides, esters and salts, on an acid equivalent basis; ( e ) the net quantity of plant protection product given in legal units of measurements; ( f ) the formulation batch number or some means of identifying it; ( g ) the particulars required under Article 6 of the Directive of 1978— (
i)the name as given in the list contained in Annex I to the Directive of 1967, of each very toxic, toxic, harmful or corrosive substance, excluding active substances, contained in the plant protection product, in concentrations of more than 0.2 percent in the case of very toxic and toxic substances, 5 percent in the case of harmful substances and 5 percent in the case of corrosive substances, (
ii)the symbols and indications as specified in Annex VIII, (iii) phrases indicating the nature of the special risks referred to in Article 6

(2)(

h)of the Directive of 1978, selected from among those contained in Annex IX and specified by the competent authority, (
iv)phrases providing safety advice concerning the use of the plant protection product, selected by the competent authority from those contained in Annexes X and XI, and (
v)for plant protection products classified

Regulation 5 of the Regulations of 1994, as being very toxic, toxic or harmful, a statement that the packaging must not be re-used for any purpose, except in the case of containers which are specifically designed for re-use, recharging or refilling by the manufacturer or distributor; ( h ) first-aid information for use in the event of accidental exposure or ingestion; ( i ) the nature of any special risks for humans, animals or the environment, by means of standard phrases selected as appropriate from those given in Annex IV; ( j ) safety precautions for the protection of humans, animals or the environment, in the form of standard phrases selected as appropriate from those given in Annex V; ( k )

Article 16

(5)of the Directive of 1991, additional phrases deemed necessary for the protection of human beings, animals or the environment, where appropriate selected from those set out in Annex XII; ( l ) the type of action of the plant protection product (e.g. insecticide, growth regulator, herbicide, etc); ( m ) the type of preparation (e.g. wettable powder, emulsifiable concentrate, etc); ( n ) the uses for which the plant protection product has been authorized and any specific agricultural, plant health and environmental conditions under which the product may be used or should not be used; ( o ) directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorization; ( p ) where necessary, the safety interval for each use between application and— (

i)sowing or planting of the crop to be protected, (
ii)sowing or planting of succeeding crops, (iii) access by humans or animals, (
iv)harvesting, (
v)use or consumption; ( q ) particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of— (
i)the crop in question, or (
ii)subsequent crops; ( r ) if accompanied by a leaflet, as provided for in paragraph 3, the sentence Read accompanying instructions before use; ( s ) directions for safe disposal of the plant protection product and of the packaging; ( t ) the expiry date relevant to normal conditions of storage where the shelf life of the product is limited to less than two years; ( u ) where relevant, the category or categories of users to which supply and use is restricted; and ( v ) the authorization number, or permission to market number, as appropriate, of the plant protection product.

(3)Notwithstanding the provisions of paragraph

(2), the information specified in subparagraphs (o), (p) and (q) of paragraph

(2)may be included on a separate leaflet accompanying the package if the space available on the package is too small. Such a leaflet shall be regarded as part of the label for the purposes of these Regulations.

(4)Labels and packaging of plant protection products shall not bear indications such as non-toxic, harmless, or other similar indication. However, information to the effect that the plant protection product may be used when bees or other non-target species are active, or when crops or weeds are in flower or other such phrases to protect bees or other non-target species may be given on the label, if the authorization relates explicitly to use during the season for bees or other specified organisms and presents minimal hazard to them.

(5)The competent authority shall notify the competent authorities of the other Member States and the Commission of each additional phrase specified and the reasons for its specification. 25 Authorization for Trials Purposes 25.

(1)The placing on the market for use in experiments and tests, of a plant protection product to which these Regulations apply, and use of such a product in experiments and tests, other than

the provisions of Regulation 26, where— ( a ) the testing or experimentation is for research or development purposes, and ( b ) the tests or experiments concerned involve any release into the environment of an unauthorized plant protection product, or of an authorized plant protection product for an unauthorized use, are hereby prohibited unless the requirements of this Regulation, in relation to authorization for trial purposes, are complied with, and the experiments and tests are carried out in compliance with the requirements specified in the Seventh Schedule, or in compliance with Irish/European Standard IS/EN 45001.

(2)The provisions of this Regulation, in relation to authorization of plant protection products for trials purposes, shall not apply to experiments or tests covered by Part B of Council Directive No. 90/220/EEC of 23 April 1990.15.

(3)Every application for authorization of a plant protection product for trials purposes, shall be made by or on behalf of the person responsible for, or on whose behalf, the research and development is to be conducted, subject to the person concerned having an office in a Member State, and shall be in the form set out in Part 1 of the Eight Schedule.

(4)Applications for authorization of a plant protection product for trials purposes, which shall be supported with the documentation specified in paragraph

(5), shall be in the English language.

(5)Every application for authorization of a plant protection product for trials purposes, shall be submitted to the competent authority at least 45 days before the date on which it is intended that the experiments or tests commence, and shall be supported with a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in the Ninth Schedule.

(6)The tests and analyses conducted for the purposes of compiling dossiers referred to in paragraph

(5), shall be carried out under agricultural, plant health and environmental conditions relevant to use of the plant protection product in question and representative of those prevailing where the product is intended to be used, and to the extent that they are carried out in the territory of the state, shall be officially recognized tests and analyses.

(7)Notwithstanding paragraph

(5), and subject to Regulation 10, applicants shall be exempted from supplying the information relevant to the active substance, except for that identifying the active substance, if— 15 O.J. No. L117/15 8/5/1990 ( a ) it is already listed in Annex I, taking into account the conditions of inclusion in Annex 1, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the relevant Annex II dossier supporting the inclusion of the active substance in Annex I, ( b ) a plant protection product containing the active substance is authorized for a provisional period

Regulation 15, ( c ) a plant protection product containing the active substance is authorized

Regulation 18, or ( d ) a plant protection product containing the active substance has been cleared

the Regulations of 1994.

(8)The competent authority shall examine every application received for the authorization of a plant protection product for trials purposes, and shall decide there on within a reasonable period, provided that it has the necessary scientific and technical resources at its disposal.

(9)The competent authority shall not authorize the placing on the market and use of any plant protection product for trials purposes unless it is satisfied that when used

the conditions and restrictions specified pursuant to paragraphs

(10)and

(11), it has no harmful effect on human or animal health and no unacceptable influence on the environment.

(10)Restrictions on use, necessary in order to avoid harmful effects on human or animal health that may arise— ( a ) through exposure of consumers of treated products to risks of dietary contamination— (

i)in excess of the Acceptable Daily Intake level (ADI) of the residues concerned, or (
ii)due to residues for which the health risks associated with exposure have yet to be established, and ( b ) through direct exposure of workers and bystanders— (
i)in excess of the Acceptable Operator Exposure Level (AOEL) for the active substance or substances concerned, or (
ii)due to exposure to active substances for which the health risks associated with exposure have yet to be established, shall, where appropriate, be attached to authorizations granted

paragraph

(8).

(11)In granting authorizations for trials purposes

paragraph

(8), the competent authority shall attach any further conditions and restrictions to each such authorization, as are necessary and relevant to avoid any harmful effect on human or animal health and any unacceptable influence on the environment, to include— ( a ) particular packaging and labelling requirements, ( b ) restrictions as to the quantity that may be placed on the market and used for trials purposes, ( c ) restrictions as to the area or areas that may be treated, and ( d ) conditions necessary to ensure that the use for trials purposes is controlled and subject to official supervision.

(12)Subject to the provisions of Regulation 36, authorizations for trials purposes— ( a ) shall be for fixed periods of 12 months, ( b ) shall be varied as to any conditions and restrictions attached, where application for such variation is made in the form set out in Part 2 of the Eight Schedule, and the competent authority is satisfied that the provisions of paragraph

(9)will be complied with under the changed conditions or restrictions, and ( c ) may be renewed for further fixed periods of 12 months, where application for such renewal is made in the form set out in Part 3 of the Eight Schedule.

(13)Experiments and tests conducted

the conditions and restrictions specified in an authorization for trials purposes, are hereby deemed to have been conducted by officially recognized testing facilities or organizations, for the purposes of these Regulations. 26 Trials Permits 26.

(1)Subject to paragraph

(2), and notwithstanding the provisions of Regulation 25, a "trials permit" shall be granted by the competent authority to a person, organization or official body involved in research or development, for specified premises and sites, to conduct tests and experiments using plant protection products for which for authorization for trials purposes has not been granted, or using authorized plant protection products for a use not yet authorised, where— ( a ) application is made by the person, organization or official body, in the form set out in Part 1 of the Tenth Schedule, and ( b ) the competent authority is satisfied that the requirements specified in paragraph

(3)are satisfied.

(2)A person, organization or official body, that holds a trials permit is hereby exempted from the provisions of Regulation 25, in relation to tests and experiments which comply with the requirements of paragraph

(6), where they are conducted

the conditions and restrictions of the trials permit specified pursuant to paragraphs

(4)and

(5).

(3)A trials permit shall not be granted for particular premises or sites, unless the applicant— ( a ) owns, or has exclusive control of premises or sites suitable for conducting trials and experiments, ( b ) owns, or has available, equipment and other facilities, necessary for conducting trials and experiments, at each such premises or site, and ( c ) holds, or an employee of his holds, appropriate professional qualifications.

(4)Each trials permit granted shall be subject to the condition that— ( a ) tests and experiments conducted

the trials permit shall be carried out in compliance with the requirements specified in the Seventh Schedule, ( b ) unless the tests and experiments are conducted by an organization or laboratory accredited

Irish/European Standards IS/EN 45002 and 45003 by the Irish Laboratory Accreditation Board to carry out such tests and experiments

Irish/European Standard IS/EN 45001.

(5)Each trials permit granted shall be subject to conditions and restrictions such that the use of plant protection products in tests and experiments conducted

the trials permit has no harmful effect on human or animal health and no unacceptable influence on the environment. The conditions and restrictions specified for each trials permit shall— ( a ) restrict its validity to the premises, site or sites specified in the trials permit, ( b ) restrict its validity to tests and experiments conducted under the direct supervision of the professionally qualified personnel specified in the trials permit, and ( c ) be conditional on an authorization for trials purposes being obtained,

Regulation 25, in each instance in which trials or experiments other than those conforming to the requirements of paragraph

(6)are to be conducted.

(6)A trials permits shall not be valid for tests and experiments involving plant protection products unless— ( a ) the conditions and manner of use are encompassed by an existing authorization for a plant protection product containing the same active substance or substances, ( b ) use is restricted to crops other than food or feed crops, ( c ) the nature of the use or of the active substance is such that residues at harvest are precluded, or ( d ) food, feed and forage crops are destroyed by burning or burying to preclude consumption by humans or animals.

(7)Subject to the provisions of Regulation 36, a trials permit granted— ( a ) shall be for fixed periods of 12 months, ( b ) may be varied as to any conditions and restrictions attached, where application for such variation is made in the form set out in Part 2 of the Tenth Schedule, and the competent authority is satisfied that the provisions of paragraph

(3)will be complied with under the changed conditions or restrictions, and ( c ) may be renewed for a further fixed periods of 12 months, where application for such renewal is made in the form set out in Part 3 of the Tenth Schedule.

(8)Experiments and tests conducted

the conditions and restrictions associated with a trials permit, are hereby deemed to have been conducted by officially recognized testing facilities or organizations, for the purposes of these Regulations. 27 Notification of Imports and Exports 27.

(1)Unless exempted

the provisions of paragraph

(2), where a person proposes to import into the State a plant protection product to which these Regulations apply, three days notice of the intended importation shall be given in writing, in the form set out in Part 1 of the Eleventh Schedule, to the competent authority on behalf of the importer specifying— ( a ) the brand name of the plant protection product, ( b ) the port, airport or other place at which it is expected that the plant protection product shall be landed or otherwise brought into the State, ( c ) the date on which the plant protection product is expected to be so transferred into the State, ( d ) the number of packs which the relevant consignment comprises (if it comprises more than one), ( e ) the pack size (given by reference to volume or weight) of the consignment or, in case the consignment comprises more than one pack size, the pack size (so given) of each such pack, and ( f ) in the case of a plant protection product being imported into the State, the destination to which the pesticide is consigned or, in lieu thereof, an address at which the plant protection product may be examined, sampled, tested or inspected pursuant to Regulation 30

(1).

(2)Where satisfied that plant protection products imported and intended for use in the territory of the State, in the first instance following importation, will be transferred to nominated warehouse or storage facilities, the competent authority may grant an exemption from the requirements of paragraph

(1)to particular importers, where ( a ) the importer has provided the address of each premises at which plant protection products concerned will be stored following importation, prior to supply or sale, ( b ) the importer notifies on an annual basis, details of all imports to the competent authority, in the form set out in Part 2 of the Eleventh Schedule, such notification to be provided by 31 January each year in relation to imports during the previous year.

(3)Where a plant protection product to which these Regulations apply, is exported out of the State, the exporter shall notify on an annual basis details of the export to the competent authority, in the form set out in Part 3 of the Eleventh Schedule, such notification to be provided by 31 January each year in relation to exports during the previous year. 28 Provisional Maximum Residue Levels 28.

(1)The Minister may from time to time specify the maximum levels of residues of plant protection products which may be contained in specified controlled products.

(2)The maximum levels of residues of plant protection products specified

paragraph

(1)shall be those established by the competent authority pursuant to subparagraph

(1)(c) of Regulation 13, subparagraph

(2)(b) of Regulation 15 or subparagraph

(2)(b) of Regulation 18 and shall remain in force until— ( a ) replaced by maximum levels subsequently specified to give effect to provisional maximum levels established by the Community

Article 4

(1)( f ) of the Directive of 1991, or ( b ) replaced by maximum levels established pursuant to Directive 76/895/EEC16, Directive 86/362/EEC17, Directive 86/363/EEC18, Directive 90/642/EEC19, Directive or 91/132/EEC20, amending Directive 74/63/EEC21. 29 .. 29.

(1)A person shall not place on the market any controlled product if— ( a ) the product contains within it or on it a residue of a plant protection product, and ( b ) the level of such residue exceeds the maximum specified in relation to the controlled product

Regulation 28

(1).

(2)A person who contravenes the provisions of paragraph

(1)shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 or imprisonment for a term not exceeding 6 months or to both. 30 Inspections, Sampling, Tests and Examinations 30.

(1)Subject to paragraph

(5), an authorised officer may at any reasonable time enter— ( a ) any place or premises in which he has reasonable grounds for believing that— 16O.J. No. L340/26, 9/12/1976 17O.J. No. L221/36, 7/8/1986 18O.J. No. L221/43, 7/8/1986 19O.J. No. L350/71, 14/12/1990 20O.J. No. L66/16, 13/3/1991 21O.J. No. L38/31, 11/2/1974 (

i)a plant protection product is being manufactured, placed on the market, stored or used, or (
ii)a controlled product is being produced, placed on the market, processed, stored or used, ( b ) any railway wagon, vehicle, ship, vessel, aircraft, container or other thing in which he has reasonable grounds for believing that a plant protection product or a controlled product is being either transported, stored or used, or ( c ) any premises in which he has reasonable grounds for believing that there are any books, documents or records relating to any business whose activities consist of or include— (
i)the manufacture, placing on the market, storage, transport or use of a plant protection product, or (
ii)the production, putting into circulation, processing or storage of any controlled product, and there or at any other place— (iii) make such examinations, tests and inspections, and (
iv)take samples

the methods described in the manual on the development and use of FAO specifications for plant protection products (Food and Agriculture Organization of the United Nations, FAO Plant Production and Protection Paper 85, Fourth Revised Edition), of any plant protection product which he finds in the course of his inspection and which he believes is or may be a plant protection product to which these Regulations apply, and (v) take samples

Commission Directive 79/700/EEC of 24 July 197922, or the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, recommended method of sampling for the determination of Pesticide Residues (Food and Agriculture Organisation of the United Nations CAC/PR5-1984), where relevant, and

other internationally accepted procedures in other cases, of any plant, plant product, soil, compost, or take samples from or of any other thing, which he finds in the course of an inspection and which he believes may have been treated or contaminated with a plant protection product to which the Regulations apply, 22O.J. No. L207/26 15/8/1979 as he may consider appropriate and provided the quantity which a sample taken pursuant to this Regulation comprises is reasonable.

(2)A person who has in any place, on any premises or in any railway wagon, vehicle, ship, vessel, aircraft, container or other thing a plant protection product to which these Regulations apply, or a controlled product, shall at all reasonable times— ( a ) afford to an authorised officer such facilities and assistance as are reasonably necessary for an inspection and for the taking of samples pursuant to this Regulation, ( b ) give an authorised officer any information which he may reasonably require regarding the purchase, importation, storage, transportation, sale, supply or use of any such plant protection product or regarding the production, purchase, importation, processing, transport, storage, sale, supply or use of any controlled product, which is within the person's knowledge or procurement, ( c ) produce to an authorised officer any document relating to the raw materials used in the formulation of any plant protection product or relating to the production of any controlled product which the authorised officer may reasonably require and when produced permit the officer to inspect and take extracts from the document.

(3)In addition to the foregoing any person who carries on the business of manufacturing, formulating, packaging, processing or marketing a plant protection product for the purposes of the Directive of 1991 shall— ( a ) keep records of all transactions regarding the plant protection product, ( b ) produce at the request of an authorised officer any records, books or other documents relating to such business which are in his possession or under his control, ( c ) permit such an officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his knowledge or under his control and which such officer may reasonably require in relation to any entries therein, ( d ) afford to any such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of any plant protection product on any premises on which such person carries on such a business, ( e ) give to such an officer any information he may reasonably require in relation to such transactions, including, in particular, information which he may reasonably require regarding any plant protection product specified by him.

(4)Where a sample is taken pursuant to this Regulation, the authorised officer concerned shall— ( a ) divide the sample into 3 parts, each of which he shall seal and mark, ( b ) give one part thereof to a designated chemist for analysis

paragraph

(5), ( c ) leave with, or send by registered post to, the defendant or his agent, a second part thereof, and ( d ) retain the remaining part thereof for possible analysis by the State Chemist

Regulation 34.

(5)Where a designated chemist receives a sample from an authorized officer in pursuance of these Regulations, he shall make analyses thereof

— ( a ) the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Recommendations for Methods of Analysis of Pesticide Residues (Food and Agriculture Organisation of the United Nations CAC/PR 8-1989), as updated from time to time, or the method included as part of the documentation approved

Regulation 8, as appropriate, and the Codex Guidelines on Good Practice in Pesticide Residue Analysis (Food and Agriculture Organisation of the United Nations CAC/PR 7-1984), in the case of residues in controlled products, and ( b ) the relevant CIPAC method (Collaborative International Pesticides Analytical Council Limited, Handbook Volume I, IA, IB, IC, and D), or the method included as part of the documentation approved

Regulation 8, as appropriate, in other cases.

(6)( a ) In any proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or any report on, a sample taken pursuant to this Regulation shall not be adduced unless, before the proceedings were instituted, one of the parts into which the sample was divided (as required by paragraph

(4)) was left with, or sent by registered post to, the defendant or his agent. ( b ) In any proceedings for an offence under these Regulations, evidence of the presence of a plant protection product to which the Regulations apply, in or on equipment capable of use for application of the pesticide, shall be evidence, until the contrary is proved, of the use of the plant protection product by the owner or person in possession of the equipment. ( c ) In any proceedings for an offence under these Regulations, evidence of the presence of a residue of a plant protection product to which the Regulations apply, in or on agricultural produce, in soil or compost or in or on surfaces or other materials which may have been treated with or exposed to the plant protection product, shall be evidence, until the contrary is proved, of the use of the plant protection product by the owner, occupier or person in possession, as the case may be. ( d ) In any proceedings for an offence under these Regulations, a certificate in the form set out in Part 1 of the Twelfth Schedule showing the results of an analysis shall, until the contrary is shown, be sufficient evidence of the facts certified to therein in relation to— (i) the presence in a plant protection product of any active substance, impurity or formulating ingredient, and the level of any such presence, or (ii) the presence of a residue of a plant protection product and the level of such residues in any controlled product, and a document purporting to be such a certificate shall be deemed, until the contrary is shown, to be such a certificate. ( e ) In any proceedings for an offence under these Regulations, each of the documents referred to in subparagraphs

(1)(

c)(
iv)and (v), and in subparagraphs

(5)(

a)and (
b)may be proved by a production of a copy thereof purporting to have been published in the Official Journal of European Communities, by the Food and Agriculture Organization of the United Nations, by the Collaborative International Pesticides Analytical Council Limited, or by the production of the document describing the method, certified by the officer-in-charge of the competent authority as being part of the documentation submitted

Regulation 8, as appropriate. ( f ) For the purpose of these Regulations, the presence of a plant protection product, to which these Regulations apply, on any premises (including any stores) where the business of marketing such a plant protection product is carried on, shall, until the contrary is shown, be sufficient evidence that the plant protection product in question is or was being placed on the market by the owner and by the occupier of such premises.

(7)If any person— ( a ) tampers with any plant protection product so as to procure that any sample of it taken pursuant to these Regulations does not correctly represent the plant protection product, ( b ) tampers with any controlled product so as to procure that any sample of it taken pursuant to these Regulations does not correctly represent the product sampled, or ( c ) tampers or interferes with any sample taken pursuant to these Regulations, he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 or to imprisonment for a term not exceeding 6 months or to both.

(8)An authorised officer shall be furnished with a certificate of his appointment as an authorised officer and when exercising any power conferred on him by these Regulations shall, if requested by any person affected, produce the certificate to that person.

(9)A designated chemist shall be furnished with a warrant of his appointment by the Minister to carry out analyses as required by these Regulations. 31 Seizure, Retention, Removal and Disposal 31.

(1)An authorised officer may seize and retain, or seize, remove and retain any plant protection product which he believes is a plant protection product to which these Regulations apply or any controlled product to which these Regulations apply and in relation to which the authorised officer has reasonable grounds for suspecting that there is or has been a failure to comply with any provision of these Regulations.

(2)An authorised officer may by a notice in writing given to the owner or to the person in apparent charge or control of a plant protection product or controlled product which has been seized under this Regulation— ( a ) require things specified in the notice to be done in relation to the plant protection product or controlled product before it is released by an authorised officer, ( b ) in the case of a plant protection product, either— (

i)require the disposal of the plant protection product by the person to whom the notice is given, in a manner specified in the notice and at the expense of the owner, or (
ii)indicate the authorised officer's intention of disposing of the plant protection product at the expense of the owner, such disposal to be, in either case, such as will prevent the said plant protection product from being placed on the market or used, and ( c ) in the case of a controlled product require the disposal of the product by the owner, or person in apparent charge or control of the product, in a manner and within a time specified in the notice and at the expense of the owner, such disposal to be such as will prevent the product being used for human or animal consumption, and in case a notice given under this paragraph requires specified things to be done in relation to a plant protection product or controlled product, the authorised officer shall retain control of the plant protection product or controlled product to which the notice relates until the requirements of the notice have been complied with.

(3)Where a notice is given under this Regulation, a person shall not, without the consent of the authorised officer by whom the notice was given sell, move, dispose of or otherwise interfere with the plant protection product or controlled product in any way pending compliance with the requirements of the notice.

(4)Any person who is aggrieved by a notice given under paragraph

(2), in relation to a plant protection product, which either requires the plant protection product to which it relates to be disposed of or indicates an intention to dispose of such a plant protection product may, not later than the expiration of a period of seven days beginning on the date of the notice, appeal against the notice to the District Court in the District Court District in which the notice has been served.

(5)Disposal of a plant protection product pursuant to a notice given under paragraph

(2)shall not take place until— ( a ) the period during which an appeal under paragraph

(4)may be taken against the notice has expired, or ( b ) an appeal under that paragraph is determined or withdrawn.

(6)(a) Where an appeal is made to the District Court under paragraph

(4), that court, if it is satisfied that— (

i)the plant protection product to which the relevant notice under this Regulation relates is one to which Regulation 3 applies, and (
ii)if the plant protection product was released, it might be placed on the market or used for purposes not authorised

these Regulations, and (iii) there has been a failure to comply with the provisions of these Regulations— shall order that the plant protection product be disposed of in the manner specified in the notice, or in such other manner as may be specified in the court's order and which, in the opinion of the court, will prevent the plant protection product from being used or placed on the market. ( b ) Where an order made by the District Court under this paragraph requires the plant protection product to which it relates to be disposed of by an authorised officer, the cost of such disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was either the owner or in apparent charge or control of the product at the time of its seizure under this Regulation.

(7)Notwithstanding paragraph

(2)and the requirements of these Regulations in relation to plant protection products, the method of disposal specified in a notice given under paragraph

(2)may include its use subject to such conditions as the authorized officer may specify in the notice, provided that the officer is not aware of any apparent risk to man or the environment by such use.

(8)In the case of a notice given under paragraph

(2)which indicates an intention to dispose of a plant protection product, the ownership of such a plant protection product shall, in the absence of an appeal by the owner against the notice to the District Court, vest in the Minister on the expiration of a period of 7 days beginning on the date of the notice. In the event of an appeal by the owner against the notice to the District Court, ownership of the plant protection product shall vest in the Minister if the court makes an order under paragraph

(5)which requires the plant protection product to be disposed of by an authorised officer.

(9)In the case of a notice under paragraph

(2)which requires the disposal at the expense of the owner of a plant protection product which has been seized under this Regulation and where there has been a failure to pay, the cost of such disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was either the owner or in apparent charge or control of the plant protection product at the time of its seizure under this Regulation.

(10)Where there has been failure to comply with a requirement of a notice given under paragraph

(2)with respect to a controlled product, an authorised officer who in pursuance of this Regulation has seized any controlled product may, on giving notice in writing to the owner, or the person in apparent charge or control of such product of his intention to do so, apply to the District Court in the District Court district in which the notice has been served for an order directing that the controlled product be disposed of (by destruction or otherwise) in a manner, specified in the order, that will prevent its being used for human or animal consumption.

(11)Where an application is made under paragraph

(10)to the District Court for an order directing the disposal of a controlled product, the Court, if it is satisfied that— (i) the controlled product to which the notice relates contains within it or on it a residue of a plant protection product in excess of the maximum specified in relation to that product

Regulation 28, (ii) if such product were released, it might be put into circulation contrary to Regulation 29, and (iii) such product if consumed would constitute a danger to human or animal health, shall order that the product be disposed of (by destruction or otherwise) in a manner, specified in the order, that will prevent its being used for human or animal consumption.

(12)Where an order is made by the District Court under paragraph

(11), the order may provide that the controlled product to which it relates shall be disposed of in the manner specified in the notice given under paragraph

(2), or in such other manner as may be specified in the Court's order and which, in the opinion of the Court, will prevent the product being used for human or animal consumption.

(13)Where an order made by the District Court under paragraph

(11)requires that a product to which it relates be disposed of by an authorised officer, the cost of disposing of the relevant product pursuant to and

the order shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was either the owner, or in apparent charge or control of the product, at the time it was seized. 32 General Offenses 32.

(1)A person who contravenes Regulation 4, 6 or 7 shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, to imprisonment for a term not exceeding 6 months, or to both.

(2)A person who — ( a ) fails to comply with the requirements of Regulations 7, 8, 9, 17, 23, 24, 25

(1), 26

(4)and

(5), 27, 30

(2)and

(3), or 31

(3), or ( b ) who obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by Regulations 30, 31 or 37, or ( c ) who in the context of Regulation 8, 11

(1), 16

(2)(b), 17, 19

(3), 25

(5), 26

(2)(a) or 27, submits false or misleading information, or who gives false information when requested to provide information under Regulation 37, shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, to imprisonment for a term not exceeding six months, or to both. 33 Prosecutions and Specific Rules of Evidence 33.

(1)An offence under these Regulations may be prosecuted by the Minister.

(2)In proceedings for an offence under Regulation 32

(1)it shall be a defence for the defendant to prove that the plant protection product to which the offence relates, was either in stock or purchased by him during the twelve month period following— ( a ) its authorization

these Regulations, or ( b ) the date of its clearance

the provisions of the Regulations of 1994, if purchased prior to the date of implementation of these Regulations. 34 Referee Analyses 34.

(1)Where an appeal is made to the District Court concerning the results of any analysis made under Regulation 30

(5), the third part of the sample shall, if the defendant so requests, be analyzed by the State Chemist.

(2)The State Chemist shall in making an analysis comply with the methods of analysis that apply in the particular case as specified in Regulation 30

(5)and issue a certificate in the form set out in Part 2 of the Twelfth Schedule to the defendant and to the designated chemist concerned. 35 .. 35. The defendant shall be liable for the cost of the analysis carried out by the State Chemist under Regulation 34 in the event that the results of that analysis confirm that there has been a breach of these Regulations. 36 Fees 36.

(1)The consideration of every application for the authorization of a plant protection product, for the renewal or modification of an authorization granted, for an extension in the field of use of an authorized plant protection product, for the renewal of an extension granted, for the authorization of a plant protection product for trials purposes, for the renewal or variation in the conditions or restrictions of such an authorization, for a trials permit, for the renewal or variation in the conditions or restrictions of a trials permit, for the inclusion of an active substance in Annex I, or for the modification of the conditions or restrictions associated with any such inclusion, shall be subject to the payment of the following fees at the times specified, that is to say— ( a ) in the case of an application for authorization of a plant protection product

Regulation 13, 15, or 18, for inclusion of an active substance in Annex I

Article 6

of the Directive, or for a modification of the conditions or restrictions associated with any such inclusion, the fee, or fees as appropriate, set out in column

(2)of Part 1 of the Thirteenth Schedule, payable to the Minister in respect of the evaluation of the dossiers set out in column

(1)of the said Part 1; ( b ) in the case of an application for the renewal of an authorization

Regulation 19

(1), the fee, or fees as appropriate, set out in column

(2)of Part 1 of the Thirteenth Schedule, payable to the Minister in respect of the evaluation of the dossiers set out in column

(1)of the said Part 1; ( c ) in the case of an application for the modification of an authorization

Regulation 19

(4), the fee, or fees as appropriate, set out in column

(2)of Part 2 of the Thirteenth Schedule, payable to the Minister in respect of the each such modification in relation to a category set out in column

(1)of the said Part 2; ( d ) an initial fee of £100 payable to the Minister shall accompany each application for the authorization of a plant protection product or for the renewal or modification of an authorisation, which payment shall be offset against the fees mentioned in subparagraphs (a), (

b)and (
c)(evaluation of each application shall not be undertaken until the balance of the relevant fee is paid); ( e ) a fee of £150 shall be payable to the Minister in each case where an application is made for a minor amendment to the packaging and labelling or to the documentation, information and materials submitted

Regulation 8

(3), where it is considered no hazard evaluation or evaluation of the performance of the plant protection product is involved or required, which fee shall not be offset against the fees mentioned in subparagraphs (a), (b) and (c); ( f ) a fee of £500 shall be payable to the Minister in each case where an application is made for a permission to market

Regulation 5

(3), which fee shall not be offset against the fees mentioned in subparagraphs (a), (b) and (c); ( g ) a fee of £200 shall be payable to the Minister in each case where an application is made for an extension in field of use of an authorized plant protection product,

Regulation 16, which fee shall not be offset against the fees mentioned in subparagraphs (a), (b) and (c); and ( h ) a fee of £100 shall be payable to the Minister in each case where an application is made for the renewal of an extension in field of use of an authorized plant protection product,

Regulation 19

(2), which fee shall not be offset against the fees mentioned in subparagraphs (a), (b) and (c).

(2)( a ) The consideration of every application for the authorization of a plant protection product for trials purposes

the provisions of Regulation 25 shall be subject to the payment of a fee of £250 payable to the Minister. ( b ) The renewal of an authorization of a plant protection product for trials purposes

the provisions of Regulation 25 shall be subject to the payment of a fee of £50 payable to the Minister. ( c ) The variation of the conditions or restrictions of an authorization of a plant protection product for trials purposes

the provisions of Regulation 25 shall be subject to the payment of a fee of £50 payable to the Minister.

(3)( a ) The consideration of every application for a trials permit

the provisions of Regulation 26 shall be subject to the payment of a fee of £1,000 payable to the Minister. ( b ) The renewal of a trials permit

the provisions of Regulation 26 shall be subject to the payment of a fee of £250 payable to the Minister. ( c ) The variation of the conditions or restrictions of a trials permit

the provisions of Regulation 26 shall be subject to the payment of a fee of £250 payable to the Minister.

(4)Authorization of a plant protection product

the requirements of these Regulations shall be revoked if, in the case such plant protection product continues to be placed on the market or used, there is a failure to pay the annual renewal fee set out in Part 3 of the Thirteenth Schedule, within 30 days of the fee falling due, but renewal of authorization of a plant protection product may be granted where application is made more than 30 days but not more than 60 days after the renewal fell due on payment to the Minister of the late annual renewal fee set out in Part 3 of the Thirteenth Schedule.

(5)In the case of a plant protection product already on the market at the time of the commencement of these Regulations, the Minister may reduce the fee payable under paragraph

(1), on a request being made to him in that behalf, where he is satisfied that the wholesale sales of the plant protection product during the previous 12 month period did not exceed 50 times the fee payable to the Minister

paragraph

(1).

(6)In the case of a plant protection product which is being placed on the market for the first time, the Minister may refund part of the fee payable

paragraph

(1), on a request being made to him in that behalf, where he is satisfied that the wholesale sales of the plant protection product during the 12 month period following the date of its authorization

Regulation 13, 15 or 18, did not exceed 50 times the fee payable to the Minister

paragraph

(1).

(7)In the case of an application for the authorization of a plant protection product for trials purposes, the fee payable under paragraph

(2)may be reduced by the Minister on a request being made to him in that behalf where the potential area of use is limited to a specialised area or specialised areas of use.

(8)A fee payable under these Regulations may be recovered by the Minister as a simple contract debt in any court of competent jurisdiction. 37 .. 37. A person who makes a claim for a reduction or a refund of fees

paragraphs Regulation 36

(5),

(6)or

(7)shall, at all reasonable times— ( a ) produce, at the request of an authorised officer, any records, books or other documents which are in his possession or under his control which substantiate such a claim, ( b ) permit the officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his knowledge or under his control and which such officer may reasonably require for the purpose of verifying the claim, ( c ) afford to such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of the relevant plant protection product if the officer considers such inspection is necessary for the purpose of verifying the claim. FIRST SCHEDULE Part 1 Annex II (Annex II to the Directive of 1991, as amended by Commission Directive No 93/71/EEC of 27 July 1993) REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I Introduction The information required shall: 1.1 Include a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below; 1.2 where relevant, be generated using test guidelines referred to or described in this Annex, in the case of studies initiated before the adoption of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority; 1.3 in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this annex has been used, include a justification, which is acceptable to the competent authority for the guideline used; 1.4 include, when required by the competent authority, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations; 1.5 include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the competent authority where: — particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or — it is not scientifically necessary, or technically possible to supply information and data; 1.6 where relevant, have been generated

the requirements of Directive 86/609/EEC23, of 24 November 1986, on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. 23 O.J. No. L358/1,18/12/1986 2.1 Tests and analyses must be conducted

the principles laid down in Directive 87/18/EEC24 of 18 December 1986, on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances, where testing is done to obtain data on the properties and/or safety with respect of human or animal health or the environment. 2.2 Notwithstanding the provisions of 2.1, during the period to 31 December 1999, tests and analyses done to obtain data on the properties and/or safety with respect to honeybees and beneficial arthropods other than bees may have been conducted by officially recognized testing facilities or organisations,

the principles laid down in the Sixth Schedule, or in compliance with Irish/European Standard IS/EN 45001, where they are conducted within the territory of the state, and

the requirements of points 2.2 and 2.3 of the introduction to Annex III to Directive 93/71/EEC, where they are conducted outside the territory of the state. PART A Chemical substances 1 Identity of the active substance The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances. 1.1 Applicant (name, address, etc.) The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact. Where, in addition, the applicant has an office, agent or representative in the territory of the State, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and telefax number of the appropriate person to contact. 1.2 Manufacturer (name, address, including location of plant) The name and address of the manufacturer or manufacturers of the active substance must be provided as must the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of product (including where relevant, individual batches). Where following inclusion of the active substance in Annex I, there are changes in the location or number of manufacturers, the information required must again be notified to the Commission and the Member States. 24O.J. No. L15/3, 17/01/1987 1.3 Common name proposed or ISO-accepted, and synonyms The ISO common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided. 1.4 Chemical name (IUPAC and CA) nomenclature The chemical name as given in Annex I to the Directive of 1967, or, if not included in that Directive,

both IUPAC and CA nomenclature, must be provided. 1.5 Manufacturer's development code number(

s)Code numbers used to identify the active substance and, where available, formulations containing the active substance, during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, must be stated. 1.6 CAS, EEC and CIPAC numbers (if available) Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported. 1.7 Molecular and structural formula, molecular mass The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided. 1.8 Method of manufacture (synthesis pathway) of the active substances The method of manufacturer, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engineering information is not required. Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized. 1.9 Specification of purity of the active substance in g/kg The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported. Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity. 1.10 Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereoisomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided. In the case of additives the content in g/kg must be provided. For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided— — chemical name according to IUPAC and CA nomenclature; — ISO common name or proposed common name if available; — CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available; — molecular and structural formula; — molecular mass; and — maximum content in g/kg. Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided— — chemical name according to IUPAC and CA nomenclature; — ISO common name or proposed common name if available; — CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available; — molecular and structural formula; — molecular mass; and — maximum content in g/kg. Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilised, if the production changes result in a changed specification of purity. Where the information provided does not fully identify a component viz. condensates, detailed information on the composition must be provided for each such component. The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Additionally the following information, where relevant, must be provided for such additives— — chemical name according to IUPAC and CA nomenclature; — ISO common name or proposed common name if available; — CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available; — molecular and structural formula; — molecular mass; and — maximum content in g/kg. For added components, other than active substances and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given— antifoaming agent buffer antifreeze dispersing agent binder stabiliser other (specify) 1.11 Analytical profile of batches Representative samples of the active substance must be analyzed for content of pure active substance, inactive isomers, impurities and additives, as appropriate. The analytical results reported must include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically should account for at least 98% of the material analyzed. The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, must be determined and reported. Data reported must include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate. Where an active substance is produced in different plants this information must be provided for each of the plants separately. In addition, where available and relevant, samples of the active substance produced in laboratory scale or pilot production systems, must be analyzed, if such material was used in generating toxicological or ecotoxicological data. 2 Physical and chemical properties of the active substance (
i)The information provided, must describe they physical and chemical properties of active substances and together with other relevant information, must serve to characterize them. In particular, the information provided must permit— — physical, chemical, and technical hazards associated with active substances, to be identified; — classification of active substance as to hazard; — appropriate restrictions and conditions to be associated with inclusions in Annex I to be selected; and — appropriate risk and safety phrases to be specified. The information and data referred to are required for all active substances, except where otherwise specified. (
ii)The information provided, taken together with that provided for relevant preparations, must permit the physical, chemical and technical hazards associated with preparations, to be identified, permit preparations to be classified, and demonstrate that preparations can be used without unnecessary difficulty, and be such that exposure of man, animals, and the environment is minimized, taking account of manner of use. (iii) The extent to which active substances for which inclusion in Annex I is sought, comply with relevant FAO specifications, must be stated. Divergences from FAO specifications must be described in detail, and justified. (
iv)In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(
s)of purification used must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg. Such justification must demonstrate that all technically feasible and reasonable possibilities for the production of the pure active substance have been exhausted. 2.1 Melting point and boiling point 2.1.1 The melting point or where appropriate the freezing or solidification point of purified active substance must be determined

EEC Method A 1 and be reported. Measurements should be taken up to 360°C. 2.1.2 Where appropriate, the boiling point of purified active substances must be determined

EEC Method A 2 and be reported. Measurements should be taken up to 360°C. 2.1.3 Where melting point and/or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs, must be reported. 2.2 Relative density In the case of active substances which are liquids or solids, the relative density of the purified active substance must be determined

EEC Method A3 and be reported. 2.3 Vapour pressure (In Pa), volatility (e.g. Henry's law constant) 2.3.1 The vapour pressure of purified activie substance must be determined

EEC Method A4 and be reported. Where vapour pressure is less than 10-5 Pa, the vapour pressure at 20 or 25°C may be estimated using a vapour pressure curve. 2.3.2 In the case of activie substnaces which are solids or liquids, volatility (Henry's law constant) of purified active substance must be determined or calculated from its water solubility and vapour pressure and be reported (in PA x m3 x mol-1). 2.4 Appearances (physical state, colour and odour; if known) 2.4.1 A description of both the colour, if any, and the physical state of both the active substance as manufactured and the purified active substance, must be provided. 2.4.2 A description of any odour associated with the active substance as manufactured and with the purified active substance, noted when handling the materials in laboratories or production plants, must be reported. 2.5 Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths 2.5.1 The following spectra including a table of signal characteristics needed for interpretation must be determined and reported: Ultraviolet/Visible (UV/VIS), infrared (IR), nuclear magnetic resonance (NMR), and mass spectra (MS) of purified active substance. Molecular extinction at relevant wavelengths, must be determined and reported. The wavelengths at which UV/visible molecular extinction occurs are to be determined and reported and must include, where appropriate, a wavelength at the highest absorption value above 290 nm. In the case of active substances which are resolved optical isomers their optical purity must be measured and reported. 2.5.2 The UV/visible absorption spectra, IR, NMR and MS spectra, where necessary for the identification of impurities considered to be of toxicological, ecotoxicological or environmental significance, must be determined and reported. 2.6 Solubility in water including effect of pH (4 to 10) on solubility The water solubility of purified active substances under atmospheric pressure must be determined

EEC Method A 6 and be reported. These water solubility determinations must be made in the neutral range (i.e. in distilled water in equilibrium with atmospheric carbon dioxide). Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported. Where the stability of the active substances in aqueous media is such that water solubility cannot be determined, a justification based on test data must be provided. 2.7 Solubility in organic solvents The solubility of active substances, as manufactured, in the following organic solvents at 15 to 25°C must be determ

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AI explanation based on the official legal text. Indicative, not a substitute for legal advice.