Date: May 31, 2012
The new Biocidal Products Regulation (BPR) (PE-CONS 3/12), adopted on 10 May 2012, and entering into force on 1 September 2013 with a transitional period for certain provisions, requires that most treated articles placed on the market in the EU contain approved biocidal active substances. This has long been the case under the Biocidal Products Directive (BPD) (98/8/EEC) for articles treated in the EU, but represents a major change for treated articles containing actives with merely internal effect imported into the EU.
Actives to be Authorized
Article 3(l) of the BPR defines treated article as "any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products." Under Article 3(a) a treated article that has a primary biocidal function is considered a biocidal product and is subject to biocidal product authorization. A treated article that does not have a primary biocidal function, for example, an article treated with a biocidal product to protect the article from fouling (materials preservation), does not require product authorization, but the active substance in the biocide must be authorized for the relevant product type (i.e. material preservation use).
Per Article 58, the person responsible for the placing on the market of a treated article must ensure that the label provides certain specified information, where:
Accordingly, under certain conditions, a treated article may need to be labeled even if no claims are made about the biocidal properties of the article.
The label must 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 (CLP) concerning alternate names used to preserve confidentiality, 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; and,
(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.
The above labeling requirements do not apply where at least equivalent labeling requirements already exist under sector-specific legislation.
The supplier of a treated article must, where a consumer so requests, provide that consumer, within 45 days, free of charge, with information on the biocidal treatment of the treated article.
The labeling must be clearly visible, easily legible and appropriately durable. Where necessary because of the size or the function of the treated article, the labeling may 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 on other methods of providing the customer with the relevant information.
Transitional measures concerning treated articles
The transitional provisions for treated articles are complex and depend on whether the active (1) is listed in Annex I of the BPD for the relevant product type, (2) was notified under Directive 98/8/EC for the relevant product type by 1 September 2013 and the decision on Annex I inclusion is still pending, or (3) contains active substances that are neither Annex I listed or notified.
In cases where a decision to include the biocidal active has been adopted in Annex I of the BPD for the relevant product type, the treated article can continue to be placed on the market regardless of whether that treated article was placed on the market before 1 September 2013 (i.e. is regarded an existing treated article) or placed on the market after 1 September 2013 (i.e. is regarded a new treated article) .
In cases where the the Annex I inclusion decision for the relevant product type is still pending (i.e. the active has already been notified and is currently being reviewed under the BPD review programme or for which an application to include the active is made before 1 September 2016), and where the treated article is regarded as an existing treated article (i.e. placed on the market on 1 September 2013), the treated article can stay on the market pending the outcome of the inclusion decision.
In cases where a non inclusion decision has been adopted for the relevant product type, all treated articles which intentionally incorporate or which are treated with that active, must be removed from the EU market regardless of whether those treated articles are regarded as new or existing either by (i) 1 September 2016 or (ii) for an additional 180 days after the date of that adverse decision, whichever is later unless a further application is made to include the active in the relevant product type before 1 September 2016.
For assistance in complying with the above obligations, please contact Herb Estreicher at +1 202.434.4334 or email@example.com.
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The Brussels office of Keller and Heckman LLP has been assisting clients on the Biocidal Products Directive and the National transitional schemes for biocides for a number of years. For further information, please contact Herb Estreicher (+1 202.434.4334, +32 (0)2 645 50 96, firstname.lastname@example.org) or Marcus Navin-Jones, (+32 (0)2 645 50 97, email@example.com).