Treated Articles

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The Biocidal Products Regulation (BPR) sets requirements for not only biocidal products themselves, but also for other materials (substances, mixtures or articles) which have been treated with, or intentionally incorporate, a biocidal product. Where such a treatment has been undertaken (unless it is during the fumigation or disinfection of premises or containers used for storage or transport and no residues are expected to remain), then the substance, mixture or article will be defined as a ‘treated article’ under the BPR.

Treatment of substance, mixture or article

Article 58 of the BPR requires that where a biocidal product has been incorporated into or used to treat a substance, mixture or article, the active substance(s) within that biocidal product is approved under the BPR for that product-type. Whilst this requirement will not have a significant impact on supply chains within the EU, where the biocidal product must be authorised for use anyway, it creates significant challenges for importers who may not be informed that a treatment has been undertaken – let alone the nature of the biocidal product used for that treatment. For substances and mixtures this situation will be difficult enough, but, for articles, a further level of complexity is introduced by the fact that the legislation does not distinguish between simple and complex (multi-component) articles. The importer of a complex article such as a sofa, therefore, would need to know details of any treatment of the wooden frame within it.

Product Types

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Labelling of treated articles

In addition to ensuring any treatment of a treated article is with biocidal products containing approved active substance(s), Article 58 also sets down labelling requirements. The Regulation states that specific elements must be included on the label of a treated article where either of the following conditions are met:

A claim is made that the treated article has biocidal properties; and/or
The conditions of the approval of the active substance used to treat the substance, mixture or article require specific labelling provisions to protect public health or the environment.

In the first case, the label must contain the following information:

A statement that the treated article incorporates biocidal product(s);
Where substantiated, the biocidal property attributed to the treated article;
The name of all active substances contained in the biocidal products;
The name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets;
Any relevant instructions for use, including any precautions to be taken, if this is necessary to protect humans, animals and the environment.

This labelling is only required by the manufacturer or importer placing the treated article on the EU market (i.e. the first supplier in the chain). However, subsequent distributors, retailers or other suppliers must provide the same information to consumers where requested within 45 days.

Distinguishing a treated article from a biocidal product

The requirements of Article 58, described above, only apply to treated articles which do not meet the definition of a biocidal product. In the case of a substance or mixture, therefore, if the treatment or incorporation imparts a biocidal function - an external biocidal effect - to the product it will be a biocidal product rather than a treated article.

Where a product which meets the definition of an article under the REACH Regulation, or is a combination of an article and a substance/mixture, only those for which a biocidal function is the primary function will be regarded as biocidal products. Any articles which are treated with a biocidal product but either: do not have perform a biocidal function; or have a biocidal function which is secondary to their primary function, will be considered treated articles.

Although it will be judged on a case-by-case basis, further information and examples are included in the guidance linked below.

Transitional measures

Treated articles were not within the scope of the Biocidal Products Directive. Therefore, the BPR provides a transition period to allow companies to ensure their active substance is supported in the EU.

By 1 September 2016, the relevant active substance/product-type combination must either be approved or supported in the Review Programme, unless the substance is listed in Annex I. For companies with an active substance/product-type combination that is not currently supported in the Review Programme, must be made by 1 September 2016. If such an application is not made, the treated article must not be placed on the market from 1 March 2017.

If the active substance/product-type combination is subject to a non-approval decision which is adopted after 1 September 2016, the affected treated articles can only be placed on the market for 180 days following the decision.

Note: there are no transitional arrangements for the labelling of treated articles; these provisions took effect from 1 September 2013.