The Biocidal Products Regulation

How this legislation affects the footwear supply chain bringing products to the European market.

by John Hubbard

The Biocidal Products Directive (BPD) – ‘98/8/EC’ – was originally published in the Official Journal of the European Union in 1998. It created a framework for the registration and assessment of the large number of active substances used to control microorganisms and pests (both vertebrate and invertebrate), as well as general preservatives. The revision of the legislation has seen some products removed from the shelves and others limited in their scope of intended application.

The BPD’s successor, the Biocidal Products Regulation (BPR) – ‘528/2012’ – was adopted in May 2012 and came into force on 1st September 2013. The focus of the regulation is moving away from the active substances that have been reviewed under the BPD, towards the products into which the substances are incorporated. Any active substance used in a biocidal product should be approved at the European Union level, after which the product is authorised at the member state level. Authorisations can apply across member states through the use of mutual recognition. If they wish, applicants can apply for a single EU authorisation which will cover all member states, unless the product is in one of the exempted product type categories.

To avoid duplication of resource, administration of the BPR has been passed to the European Chemicals Agency (ECHA). This is because there are a number of crossovers with the REACH regulation, which ECHA was created to enforce. The aim of the regulation is to improve the operation of the European market for biocidal products, and to protect human health and the environment.

Footwear under the BPR

Some products that had previously been outside the scope of the BPD will be drawn in to the BPR. These include items with antibacterial active substances used to protect the goods in transit (referred to as ‘treated articles’) or have been incorporated into materials to prevent deterioration during wear or the development of odours from sweat. These will be considered as ‘biocidal products’, and will include anti-bacterial insoles or lining materials.

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

The key product types for footwear are:

• product type 1 – human hygiene disinfectants
• product type 9 – fibre, leather, rubber and polymerised material preservatives.

From 1st September 2013, all biocides used in treated articles must either be approved under the old BPD or going through the approval process. If a claim is being made for biocidal properties of a product, it will be need to be labelled according to the BPR from this date. The label must be easy to understand, visible for consumers and contain the following information:
i) ‘a statement that the treated article incorporates biocidal products’
ii) ‘where substantiated, the biocidal property attributed to the treated article’
iii) ‘without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products’
iv) ‘the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets’
v) ‘any relevant instructions for use, including precautions to be taken because of the biocidal products with which an article was treated or which it incorporates’.

If the conditions of approval for a substance require it, labelling may be necessary for a treated article which contains a biocide but for which no biocidal claim is made.

When a decision is taken not to approve an active biocidal substance, a period of 180 days is given from the date of the non-approval decision to remove all products from sale which contain that substance.

Publishing Data

This article was originally published on page 38 of the May 2014 issue of SATRA Bulletin.

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