BIOCIDAL PRODUCTS (IMPLEMENTING) [ S.L. 427.108 1 SUBSIDIARY LEGISLATION 427.108 BIOCIDAL PRODUCTS (IMPLEMENTING) REGULATIONS 10th October, 2025 LEGAL NOTICE 230 of 2025. 1.
(1)The title of these regulations is the Biocidal Products (Implementing) Regulations. Citation and scope.
(2)The scope of these regulations is to implement the requirements of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
- requires: In these regulations, unless the context otherwise Interpretation. "Act" means the Product Safety Act; Cap.
- "Director General" shall have the same meaning as assigned to it in the Act; "Regulation (EU) No 528/2012" means Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
- The Technical Regulations Division within the Malta Competition and Consumer Affairs Authority as established by article 19 of the Malta Competition and Consumer Affairs Authority Act, shall be the competent authority responsible for the application of these regulations within the meaning of Article 81 of Regulation (EU) No 528/
- Establishment of the competent authority. Cap.
- With reference to Articles 27 and 53 of Regulation (EU) No 528/2012, the language used on the labels shall be that as indicated in the Schedule. Language requirements for labelling of biocidal products. 5.
(1)Biocidal products which contain active ingredients or active substances which are not included in the approved list specified in Article 9
(2)of Regulation (EU) No 528/ 2012 and which are undergoing evaluation, shall be notified by means of an application to the Technical Regulations Division before being placed on the market. Notification of biocidal products.
(2)The application referred to in sub-regulation
(1)shall at least include the following information: (
- a)safety data sheets of all the hazardous ingredients 2 [ S.L. 427.108 BIOCIDAL PRODUCTS (IMPLEMENTING) of the product; (
- b)original labels of the product; (
- c)a copy of the authorisation certificate issued by an EU Member State; (
- d)product; a declaration of the chemical composition of the (
- e)a letter of access as defined in point (
- t)of Article 3 of Regulation (EU) No 528/2012.
(3)The applicant shall also provide documented evidence that the supplier is included in the updated version of the list referred to in Article 95 of Regulation (EU) No 528/2012 regarding the product type to which the product belongs.
(4)The Director General shall determine the application within a reasonable period which shall not exceed forty-five
(45)working days from the date of receipt of an application: Provided that such period may be suspended until all relevant information has been submitted. Penalties. 6. Part IV of the Act shall apply to any offence carried out in breach of Regulation (EU) No 528/2012 and these regulations. SCHEDULE (regulation 4) Labelling Requirements according to the Product Type Product Type (PT) Language Requirements (According to Annex V of Regulation (EU) No 528/ 2012) PT 1 PT 2 PT 3 PT 4 PT 5 PT 6 PT 7 PT 8 PT 9 PT 10 PT 11 Maltese or English Maltese or English Both Maltese and English* Maltese or English Maltese or English Maltese or English Maltese or English Maltese or English Maltese or English Both Maltese and English* Maltese or English BIOCIDAL PRODUCTS (IMPLEMENTING) PT 12 PT 13 PT 14 PT 15 PT 16 PT 17 PT 18 PT 19 PT 20 PT 21 PT 22 [ S.L. 427.108 Both Maltese and English* Maltese or English Both Maltese and English* Both Maltese and English* Both Maltese and English* Both Maltese and English* Both Maltese and English* Both Maltese and English* Both Maltese and English* Maltese or English Maltese or English 3