This page provides information on the requirements, including transitional measures, for treated articles under the EU Biocides Regulation 528/2012 (EU BPR).
The EU Biocides Regulation 528/2012 (EU BPR) contains provisions which apply not only to biocidal products but also to all articles, which have been treated with or incorporate a biocidal product.
In particular, articles can only be treated with active substances which have been approved in the EU for that purpose. This is a significant change to the previous requirements under the Biocidal Products Directive (BPD), where articles imported from outside the EU could be treated with substances not allowed in the EU.
Article 3 of the EU Biocides Regulation 528/2012 (EU BPR) defines a treated article as “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products”.
Premises or containers used for storage or transport which are treated with biocidal fumigants or disinfectants and where no residues are expected to remain, are not considered to be treated articles.
Complex articles (eg a sofa) are affected even if only one component of the end article contains a biocide (eg a preservative in the wooden frame of sofa).
The table below gives examples of the HSE current view of what is a treated article and what is a biocidal product, this could be subject to change if further guidance is published at the European level.
|Type of article||Treat article or biocidal product|
|Article treated with/incorporates a biocide (e.g. a wooden bench painted with wood preservative) with the sole intention of controlling organisms harmful to the treated article/material itself||Treated Article must comply requirements in Article 58 of EU Biocides Regulation 528/2012|
|Article is treated with/incorporates a biocide and the primary function of the article is not as a biocide (e.g. odour free/ stay fresh antibacterial sock)||Treated Article must comply requirements in Article 58 of EU Biocides Regulation 528/2012|
|Article is treated with /incorporates a biocide and the primary function of the article is as a biocide (e.g. antibacterial wipe)||Biocidal product which requires authorisation|
The requirements for treated articles can be found in Article 58 of EU BPR and these apply to treated articles that are not themselves biocidal products. If an article is considered to be a biocidal product in its own right – so if the treated article has a primary biocidal function – then it will have to comply with the requirements for biocidal products, details of which are on our making products available on the market page.
EU BPR prohibits placing on the market of the treated article unless all active substances in the biocidal product it was treated with/incorporates are Approved for relevant Product Type and use under EU BPR, and any specified conditions or restrictions of relating to the active substances are met.
Manufacturers, importers or others who place treated articles on the market may also have to include specific information on labels on the treated articles they place onto the market.
Finally, anyone supplying treated articles on the market must provide, free of charge when requested, information on the biocidal treatment of the treated article. This information must be provided within 45 days (Article 58 (5).
Manufacturers, importers or others who place treated articles on the market are required to label treated articles when:
The label on a treated article must then contain the following information:
Regardless of whether a claim about the article’s biocidal properties are made or if the conditions of the approval of the active substance require it, manufacturers, importers or other who place treated articles on the market also have to label the article with any relevant instructions for use, including any precautions to be taken, if this is necessary to protect humans, animals or the environment.
The labelling should 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 when it is being placed on the market. In the UK, the label must be in English.
The labelling requirements mentioned in Article 58 apply to treated articles placed on the EU market from 1 September 2013.
The company responsible for placing the treated article on the market is responsible for labelling it.
The current UK understanding of the labelling requirement is that the person first placing the treated article on the market must label it in accordance with the requirements and these labelling requirements do not apply to anyone who subsequently makes available on the market that same treated article – but if you take a treated article and incorporate it into a more complex article (using preserved wood in the frame of a sofa for example) then the company placing that complex article on the market may need to meet any necessary labelling requirements.
As the provisions for treated articles have changed from the previous position under the old BPD, 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.
Article 94 of EU BPR allows for treated articles to continue to be placed on the market until the approval for the relevant product type of the active substance(s) in the biocidal product the article was treated with or incorporates. If the active substance is not already within the EU BPR review programme for the relevant product type, then an application for the approval of the active substance(s) for the relevant product-type has to be submitted to the European Chemicals Agency (ECHA) at the latest by 1 September 2016.
If an active substance is not supported under this transitional measure the treated articles must be removed from the market by 1 March 2017.
Where an active substance is supported under this transitional measure by 1 September 2016 but a decision is made after 1 September 2016 to reject the application or not to approve the active substance for the relevant use, the treated articles must be removed from the market within 180 days of that decision.
Before you place the treated article on the UK market you will need to ensure that the active substance is either Approved for that Product Type, or is under review for that Product Type. If you are unsure if the active substance is Approved or supported for review for your Product Type, details of how to check this are on our active substance status page.
The EU Commission have published further guidance on treated articles which goes into much more detail on specific issues such as what is a primary biocidal function, claims for biocidal properties and labelling requirements. This guidance also includes ‘Decision Trees’ to help you decide if your article is a treated article or a biocidal product.