New EU Biocidal Products Regulation for Treated Articles

HONG KONG - Nov. 25, 2013 - PRLog -- The new regulation simplifies and harmonizes the procedures for authorization, improves the European single market regarding products containing biocidal active substances, and ensures that all biocidal products on sale are safe for human health and the environment.

Biocidal Products Regulation (BPR)

Biocides are chemicals used to control organisms that are harmful to human and animal health and to the environment, such as pests and germs (i.e. molds and bacteria). Biocides include insect repellents, disinfectants and industrial chemicals like anti-fouling paints for ships, construction material preservatives and antibacterial treatments for textiles.

The BPR was adopted on 22 May 2012 (3) and came into effect on 1 September 2013 with a transitional period for certain provisions. The new Regulation requested all biocidal products must be authorized before they are placed on the EU market. Articles that have been treated with biocidal products may be placed on the market only if all the active substances within the article have been approved for the relevant product type and use. According to Article 3 of the BPR, a “Treated article” means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. It should be noted that a treated article that has a primary biocidal function shall be considered a biocidal product.

New Requirements for ‘Treated Articles’ to Ensure Product Safety

The BPR requires manufacturers and importers of treated articles to ensure that products are labeled according to the Regulation and labels for treated articles must be used when:

- A claim is made that the treated article has biocidal properties, or
- It is required in the conditions of the approval of the active substance(s) contained in the biocidal product used to treat the article.

Manufacturers and importer shall ensure that all treated articles placed on the EU market should contain only approved active substances and also are obligated to provide a label containing specified information listed according to the BPR Article 58 (3).

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 (CLP), the name of all active substances contained in the biocidal products;
d) The name of all nanomaterial 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 articles was treated or which it incorporates.

Remark: The above labeling requirements do not apply where at least equivalent labeling requirements already exist under sector-specific legislation.

The labeling should be clearly visible, easily legible and appropriately durable. Where necessary because of the size or the function of the treated articles, the labeling 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. The supplier of treated articles shall provide the consumers with information about the biocidal treatment of the treated article free of charge when request and within 45 days.

Transitional Measures for Existing Treated Articles

From 1 September 2013, the active substances contained in a biocidal product used in the treatment of the new treated articles, have to be approved for the relevant product-type of the active substances.

As treated articles were outside the scope of the previous Directive 98/8/EC, Article 94 of EU BPR allows a transition period in certain circumstances for active substances to be supported for approval so that they can continue to be present in treated articles placed on the EU market before 1 September 2013.

For active substances which are not yet in the approval process, there is a transition period until 1 September 2016. To keep the treated article on the market, the company will need to submit a complete application dossier on the active substance by that date. The active substance dossier must include data on the relevant product-type.

If a non-approval decision is made for an active substance(s) used to treat the article, the treated articles must be removed from the market with 180 days of that decision or 1 September 2016, whichever is the later.

References:

(1) Regulation (EU) No. 528/2012 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:...)

(2) ECHA News (http://echa.europa.eu/view-article/-/journal_content/titl...)

(3) SGS SG No. 114/12 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/0...)

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