New EU Biocidal Products Regulation including New Requirements for Food Contact Materials and Treated Articles likely to be adopted in 2010
The 1998 Biocidal Products Directive (" BDP" ) regulates the placing on the market of biocidal products and harmonizes the European market for biocidal products and their active substances.
The main principle of the BPD is that biocidal products may only be placed on the market if they have been authorized at the Member State level and if they contain an active substance that has been assessed and included in the Community positive list of substances (Annex I of the BPD).
After over ten years of implementation, a review undertaken by the European Commission identified several problems with the existing legislation regarding notably costs, overly stringent data requirements, and the current status of treated articles.
The European Institutions are currently preparing the revision of the BDP which will simplify the current legislation and will aim at solving problems identified during the implementation of the Directive. In June 2009, the European Commission and the Council made a proposal (COM (2009) 267) which is currently awaiting the European Parliament's decision, expected in April 2010. The key issues of the revision are described below:
A) Simplification and clarification of procedures
1) Change of legal form
The Directive will be turned into a Regulation. As a result, there will be no need for national transposition measures, which is also expected to ensure more harmonised implementation of the regulatory framework in the Member States.
2) The data waiving procedure
In the current version of the BPD, there is a lack of clarity on the application of the data waiving requirements. The revision aims at clarifying the data waiving mechanisms as follows:
- Align and clarify the grounds for data waiving with the REACH Regulation
- Oblige the Member States ("MS") to inform applicant of their right to request a waiver including the grounds for waiving and provide assistance to applicants
3) Low risk substances
The current BPD provides for simplified procedures of authorization for low risk substances (Annex IA and Annex II (B)). However, such procedures have never been used so far. The revision will repeal them and replace them by a system of direct authorizations for low risk products at the EU level, aligned with the REACH exemption regime.
B) Data-sharing issues
The current BPD has no mechanism for mandatory data sharing. The revision will impose mandatory data sharing for vertebrate animal study and set ups an efficient dispute resolution mechanism.
C) Simplification of product authorisation and harmonisation of fees
The current system is a national based authorisation system to which the mutual recognition principle apply. The system poses a problem in so far as there is a lack of adequate resources at the national level to handle the great number of biocidal substances and products that need to be authorized or re-authorized. The revision proposes to make the following changes:
1) Clarification and strengthening of the authorization and mutual recognition procedure
The authorities propose to simply the mutual recognition and conflict resolution mechanisms notably by allowing MS to initiate mutual recognition. In addition, it is proposed to set up a single community authorisation system according to which:
- after being authorized in one MS, products could be placed on the market of other MS with no need to additional administrative procedures other than complying with labelling rules
- Include a safeguard clause allowing MS to refuse a product in certain pre-defined circumstances
- Set up a dispute resolution mechanism
2) Harmonization of fees
The current system is a national-based fee system where the fees may vary from one Member State to the other from 10000€ to 354000€ for the evaluation of an active substance and from 1000€ to 70000€ for product authorisation. In addition, since the fees apply to each PT, up to 1 million Euros can be paid for a substance in 13 PTs.
The authorities wish to harmonise and centralize the fee system as well as set up reduced fees for small and medium-size enterprises (SMEs.)
D) Articles treated with biocidal products
The current scope of the BPD only covers active substances and biocidal products and not articles or materials treated against organisms harmful to protect the articles itself i.e. for internal effect. Currently, the BPD regulates only treated articles or materials when the biocide is released for external effect. For instance, a sleeping bag with mosquito repellent is covered by the BPD as the biocide is intended to have an external effect. In contrast, wood treated with a biocide to prevent the deterioration of the wood itself is not covered by the BPD since the biocide is intended to have an internal effect i.e. protect the wood itself from deterioration.
This situation creates discrimination for EU manufacturers since certain substances will be banned in the EU for "treating" the articles but import of treated articles with those banned substances may occur.
The revision of the BPD envisages bringing all treated articles within the scope of the revised PBD. The foreseen system follows a three-step approach:
1) Step 1: Assessment
- For substances already assessed and listed in Annex I or IA for which a set of basic data already exist and data protection is in order, the revision to the BPD provides for a check of the proposed use with available exposure scenario, dosage, efficacy, behaviour in articles after incorporation.
- For substances not previously assessed, the revision provides for a full evaluation of the substance for inclusion under Annex I for that product type.
2) Step 2: Impose use conditions
When the product is authorised in at least one Member State after having been assessed, the revision would impose use conditions describing how to apply the product in the article and conditions of use, storage and disposal.
3) Step3: Labelling requirements
The revision would impose labelling requirements for all or specific types of articles.
Labels would need to include the following indications:
- "articles treated with approved biocide"(+ conditions of use and name of the active substance) ; and
- "name of the product and manufacturer/seller" and
- Authorisation number
E) Food Contact Materials
Article 82 of the Commission proposal would bring biocidal products which are food contact materials into the scope of the BPD. There would a transition period of some 6.5 years for products already on the market at the time of the promulgation of the revised BPD.
For more information please contact Herb Estreicher at 202-434-4334; email@example.com.