Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

CHAPTER XIII TREATED ARTICLES

Article 58 Placing on the market of treated articles

1. This Article shall apply exclusively to treated articles that are not biocidal products. It shall not apply to treated articles where the sole treatment undertaken was the fumigation or disinfection of premises or containers used for storage or transport and where no residues are expected to remain from such treatment.

2. A treated article shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met.

3. The person responsible for the placing on the market of such a treated article shall ensure that the label provides the information listed in the second subparagraph, where:

• in the case of a treated article containing a biocidal product, a claim is made by the manufacturer of that treated article regarding the biocidal properties of the article, or

• in relation to the active substance(s) concerned, having particular regard to the possibility of contact with humans or the release into the environment, the conditions associated with the approval of the active substance(s) so require.

The label referred to in the first subparagraph shall provide the following information:

(a) a statement that the treated article incorporates biocidal products;

(b) where substantiated, the biocidal property attributed to the treated article;

(c) without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;

(d) the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets;

(e) any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.

This paragraph shall not apply where at least equivalent labelling requirements already exist under sector-specific legislation for biocidal products in treated articles to meet information requirements concerning those active substances.

4. Notwithstanding the labelling requirements set out in paragraph 3, the person responsible for the placing on the market of a treated article shall label it with any relevant instructions for use, including any precautions to be taken, if this is necessary to protect humans, animals and the environment.

5. Notwithstanding the labelling requirements set out in paragraph 3, the supplier of a treated article shall, where a consumer so requests, provide that consumer, within 45 days, free of charge, with information on the biocidal treatment of the treated article.

6. The labelling shall be clearly visible, easily legible and appropriately durable. Where necessary because of the size or the function of the treated article, the labelling shall be printed on the packaging, on the instructions for use or on the warranty in the official language or languages of the Member State of introduction, unless that Member State provides otherwise. In the case of treated articles that are not produced as part of a series but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the customer with the relevant information.

7. The Commission may adopt implementing acts for the application of paragraph 2 of this Article, including appropriate notification procedures, possibly involving the Agency, and further specifying the labelling requirements under paragraphs 3, 4 and 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

8. Where there are significant indications that an active substance contained in a biocidal product with which a treated article is treated or which it incorporates does not meet the conditions laid down in Article 4(1), Article 5(2) or Article 25, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or Article 28(2).