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Biocidal Products Regulation

Treated articles

How to comply with the BPR for placing on the market treated articles which have been treated with, or include, biocidal products containing active substances?
According to Article 58(2) of the BPR, only treated articles that have been treated with or include biocidal products containing active substances included in the list drawn up in accordance with Article 9(2) (Union list of approved active substances) for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met can be placed on the EU market. The active substances included in Annex I to Directive 98/8/EC have been transferred to the Union list of approved active substances as of 1 September 2013.
 
The BPR also requires that the person responsible for the placing on the market of such a treated article shall ensure that the treated article is labelled when: 
 
1. a claim that the treated article has biocidal properties is made
2. it is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article
 
The label shall provide the information referred to in Article 58(3) of the BPR and needs to be easily understandable and visible for consumers.
 
More information on treated articles can be found in the ‘Note for Guidance on Frequently asked questions on treated articles' available on the ECHA website at:
 
Note that Article 94(1) of the BPR (amended by the Regulation (EU) No. 334/2014 of 11 March 2014) seeks to allow the placing on the market of articles treated with biocidal products containing active substances which, albeit not yet approved, are being evaluated, either in the context of the work programme referred to in Article 89(1) of the BPR or based on an application submitted by 1 September 2016 pursuant to Article 94(1). 
 
The text of the Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 (BPR) concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market, is available at:
Is my product a treated article, a biocidal product or neither?
The decision on whether a product is a biocidal product, a treated article or neither will always have to be taken case-by-case, considering all properties and functions, as well as the intended use of an article. 
 
A claim, for instance that an article itself is protected by a biocidal treatment, is likely to be considered a claim about a biocidal property rather than indicating a biocidal function, and is unlikely to drive a decision that the article would be considered a biocidal product. 
 
Member States may request the European Commission, according to Article 3(3) of the BPR, to take a decision on whether a product is a biocidal product, a treated article or neither. 
 
More information on treated articles can be found in the Note for Guidance on Frequently asked questions on treated articles available on the ECHA website at:
 
The guidance includes a decision tree which may help deciding whether an object treated with or intentionally incorporating one or more biocidal products is a treated article, a biocidal product or neither.
Does the BPR foresee transitional measures for the labelling and information requirements for treated articles?
The BPR does not foresee transitional measures for the labelling of treated articles. This means that all treated articles placed on the market from 1 September 2013 onwards have to comply with the labelling and information requirements set out in Article 58(3) and (4) of the BPR. It has to be noted that the provisions of Article 58(3) and (4) concern the ‘placing on the market', and not the subsequent supply, of the treated article, and that there is no mandatory labelling of all treated articles already present in the supply chain on 1 September 2013. 
 
It must be emphasised that the aim of the legislator when imposing a labelling requirement for treated articles is to enable consumers to make informed choices, facilitate enforcement and provide an overview of their use. It is for the person placing the treated article on the market to make sure that this aim is respected while fulfilling the labelling requirements for treated articles.
Does Article 95 of the BPR apply to treated articles, i.e. can a mixture or article only be treated with or intentionally incorporate a biocidal product containing an active substance if the supplier has submitted a dossier or a letter of access to ECHA?

The requirements of Article 95 do not apply to active substances used only in treated articles governed by Article 58 of BPR. Article 95 applies only to active substances placed on the EU market in biocidal products, or with the intention of being used in biocidal products.

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