Last reviewed 27 March 2014
In the first of a two part feature, Dr Chris Vance looks at the current status of the EU Biocidal Products Regulation (BPR) — Regulation (EU) No. 528/2012, and highlights how it differs from its predecessor, the Biocidal Products Directive.
1. BPR overview
The BPR was published in the Official Journal of the EU on 27 June 2012 and applied from 1 September 2013, with transitional periods for certain provisions. As a regulation, it applies across all EU Member States without the need for national implementing legislation. The predecessor, the Biocidal Products Directive (BPD) (Directive 98/8/EC), was itself repealed also with effect from 1 September 2013.
The BPR has some 97 Articles and 7 Annexes and concerns the placing on the market and use of biocidal products. These are products which are used to protect humans, animals, materials or articles against harmful organisms, by the action of Active Substances contained in the Biocidal Product.
The European Chemicals Agency (ECHA) is responsible for the co-ordination and management of the Regulation at Union level. The Competent Authorities of Member States (the Health and Safety Executive (HSE) in the UK) continue their national roles.
As with the BPD, all biocidal products require an authorisation before they can be placed on the market, and the active substance(s) contained must be previously approved. There are, however, certain exceptions to this principle. For example, active substances not yet approved but included in the ongoing EU review programme as well as biocidal products containing these substances, can be placed on the market while awaiting the final decision on the active substance approval.
The approval of active substances takes place at Union level and the subsequent authorisation of biocidal products at Member State level. The authorisation can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of biocidal product authorisation at Union level.
A dedicated IT platform, the Register for Biocidal Products (R4BP 3), is used for submitting applications and exchanging data and information.
The new BPR is complex and as ever, the devil lies in the detail. This report summarises some of the main changes but the ECHA and HSE websites should be consulted for full details of the regulation text, amendments, guidance documents, active substance status, Q&As, etc.
2. Products newly in scope of the BPR
Some types of products that were not in scope of the BPD are, from 1 September 2013, within scope of the BPR. These include:
products where the biocide is generated in-situ
vermicides (worm killers) and other invertebrates not covered by the BPD are now included in product type 16
product type 13 has been expanded to include preservatives for fluids used for working or cutting glass or other materials, as well as metal
treated articles (see below).
The BPR includes Transitional Measures in Article 93 and 94 for such products that are newly within scope.
The inclusion of treated articles is one of the main changes in the BPR.
A “treated article” is defined as any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. A treated article can, for example, be a wooden bench painted with a wood preservative, or an emulsion paint containing an in-can biocidal preservative.
Where in such cases no biocidal claim is made for the treated article, other than protection of the treated article/material itself, then the treated article is not a biocidal product and does not require authorisation. It must, however, comply with the treated article provisions. On the other hand, if an article is treated with or incorporates a biocide and the primary function of the article is as a biocide (eg antibacterial wipes), then such an article is itself a biocidal product which requires authorisation.
From 1 September 2013, articles can only be treated with biocidal products containing active substances approved or under evaluation in the EU for the relevant product type. Under the previous BPD, treated articles imported from non-EU countries could be treated with substances not approved in the EU. Ensuring compliance places significant new obligations, notably on importers of treated articles into the EU.
Further to this new requirement, for treated article active substances not yet in the approval process, there is a transition period until 1 September 2016. Where a treated article was already on the market on 1 September 2013 (subject to clarification, discussed further in part 2 of this article), in order to continue to place it on the market, the company will need to submit a complete application dossier on the active substance by the September 2016 date. The active substance dossier must include data on the relevant product type.
Companies must also be ready to provide consumers with information about the biocidal treatment of the article they are selling. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days.
Manufacturers and importers of treated articles also need to ensure that products are labelled according to both BPR and CPL. Article 58 of the BPR specifies the labelling requirements for treated articles (including naming all active substances) where the treated article is not itself a biocidal product. The BPR specific labelling is required when:
a claim is made by the manufacturer of the treated article regarding the biocidal properties of the article, or
it is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article.
The labelling requirements apply to treated articles placed on the EU market from 1 September 2013, although there is some debate on the timing which is due to be “clarified” when the BPR is amended (as will be discussed in Part 2 of this article).
3. Approval of active substances
Subject to certain conditions, active substances will not be approved if they have been classified as Category 1A or 1B carcinogens, mutagens or reproductive toxins, or if they are considered as having “endocrine-disrupting” properties, or if they meet the criteria for being PBT or vPvB. If, exceptionally, such active substances are approved, they, together with other substances such as respiratory sensitisers (See Article 10), will become candidates for substitution.
Those active substances whose Member State evaluation had not been completed by 1 September 2013 (ie the majority) will be evaluated according to the BPR including the above new provisions.
4. Active substance suppliers
Article 95 of the BPR has been introduced to eliminate “free riders” among active substance suppliers.
All active substance manufacturers and importers placing active substances on the EU market must contribute to the costs. As of 1 September 2013, companies that have not already submitted their own dossier on an active substance under the BPD or BPR must either submit a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier to the ECHA.
To facilitate this requirement, the principles of mandatory data sharing have been extended in the BPR.
The ECHA will publish a list of persons who have made a successful submission of the required information. From 1 September 2015, a biocidal product cannot be placed on the EU market if the manufacturer or importer of the active substances contained in the product, or where relevant, the importer of the biocidal product, is not included in the list.
5. Authorisation of biocidal products
The BPR introduces the possibility to have certain biocidal products (see Article 42) authorised at Union level. This will allow companies to place their biocidal products on the market throughout the entire Union, without the need to obtain a specific national authorisation. The list of biocidal products with union authorisation will be published on the ECHA website.
The “product family” concept (Article 3,1(s)) is a development from the “frame formulation” of the BPD. All products within a biocidal product family are covered by one authorisation under the BPR.
A biocidal product family is a group of biocidal products that are used for similar purposes and contain active substances with the same specification. The family also has specified variations in composition of the products to ensure that the level of risk is not increased or the efficacy of the product is not reduced. Furthermore the classification, hazard and precautionary statements for all products within the family have to be the same or less “severe” than in the product first authorised.
The simplified authorisation procedure aims to encourage the use of biocidal products that are less harmful for the environment, human and animal health. To be eligible, the provisions of Article 25 must apply. These include the absence of substances “of concern” (see Article 3.1(f)) and nanomaterials, and that the handling of the biocidal product and its intended uses do not require personal protective equipment.
Where a simplified authorisation is granted, the biocidal product may be made available on the market in other Member States without the need for mutual recognition.
National authorisation and mutual recognition
Companies planning to sell their products in one EU Member State (MS) must apply for authorisation in that country.
If a company wishes to extend the national authorisation to other markets, it can ask other MSs to recognise it. Companies can apply for mutual recognition either in sequence or parallel.
Where a biocidal product contains an active substance identified as a candidate for substitution, the MS carrying out the authorisation review should carry out a comparative assessment (Article 23). If there is already an authorised product which is sufficiently effective, presents no other significant economic or practical disadvantages and does not affect the occurrence of resistance in the target organism, the new product will be restricted or prohibited.
To be continued…