October 7, 2010 by Melanie Gross
Revisions to the Biocidal Products Directive and the new Biocidal Products Regulation
We have been following developments on biocides regulation in the EU and OECD for many years. Recent developments in Europe are exciting and promise at least some improvements in the way that biocides are authorised. There is also an interesting and much needed convergence of concepts and approaches across the regulation of biocides, plant protection products, and industrial chemicals (under REACH), although this convergence still remains far from complete.
The Biocidal Products Directive 98/8/EC was adopted in 1998, and encompasses a large review programme of all existing biocides (phased in across 23 Product Types [PTs]), while at the same time authorising new biocides being placed on the market. When active substances are authorised for use they are included into Annex 1 or 1A . Once the decision has been made to include an active substance in Annex 1 there is a two year period to allow for the submission of dossiers to authorise products (1st authorisations, followed by mutual recognition applications) containing the active ingredient.
The review programme of existing actives is large and cumbersome and is not progressing to time. A mini-revision of the Directive (COM(2008)618 ) has been passed to prolong the review programme to 2014. A progress report from the Commission suggests that even this is going to fall at least five years short, as there are 250 active substances still to be reviewed. In a major revision (COM(2009)267) a proposal for a new biocides regulation was made, following consultation with Member States and stakeholders, plus an impact assessment.
The main reasons for revision of the Directive and the need for a direct Regulation are the high costs of compliance (in particular a problem for SMEs), and the need to simplify and streamline the process, clarify and address shortcomings, and close loopholes. Clear evidence of the need for this is that around two-thirds of active substances available before the original Directive was implemented are not available any longer. The unwillingness of many companies to proceed with authorisation is often based only on the large costs involved and not because of any unacceptable risks posed by use of the substance. This is further reflected in the fact that R&D into new actives has slowed down considerably.
Features of the new Biocidal Products Regulation
The following are the main features under discussion by Council on the revised version of the Regulation (6564/2/10 REV2), which should be adopted in 2011/12 and in force from 2013. The proposed regulation received its first hearing in Parliament during Plenary on September 22nd and was approved with 550 votes in favour, 22 against and 80 abstentions.
- Definition of a biocidal product [Article 3(1)(a)]. The latest text now excludes certain treated articles such as impregnated chopping boards and underwear, because their primary intention is not to destroy harmful organisms (but to chop up produce, or cover our private parts!) This makes the regulation more workable. However, articles may only be treated with biocidal products authorised for that purpose in at least one Member State. Treated articles will need to be labelled as such, which could prove highly onerous and potentially unworkable.
- Exclusion criteria for Annex I entry [Article 5(1) and (2)]. Substances that are CMR Cat 1A or 1B, endocrine disruptors under REACH, PBTs or vPvBs under REACH, or POPs cannot be entered onto Annex I. Exclusion criteria based on hazard criteria is a feature of the proposed revision that industry is generally opposed to. Many feel that the focus should be on the safe use of substances, which should be based on a risk assessment, analogously to REACH. However, a number of derogations are accepted, such as negligible exposure of people or the environment, the substances are necessary to control a serious danger to public health, or non-inclusion would cause disproportionate negative impacts, and there are no suitable alternatives. This means that even though hazard-based criteria will still be used when assessing products, there is a socioeconomic means of maintaining the use of apparently hazardous substances in products.
- There remains a reluctance on the part of some Member States to accept that there could be such a thing as a “low risk” biocide, which could merit a lighter regulatory touch. A moment’s reflection on the different risks to humans and the environment posed by a mouse trap containing a second-generation anti-coagulant rodenticide and one that simply uses CO2 should be enough to show that this position is scientifically untenable.
- Mutual recognition should be strengthened across the EU [Articles 24a, 25, 26, 27, 28 and 32], with a co-ordination group to agree mutual recognition and resolve differences, with referral to the Commission if any differences cannot be resolved.
- Comparative risk assessment remains a problem, because it remains very hard to do in a fair, comprehensive and cost-effective way. This is an issue that ECHA’s socioeconomic analysis committee (SEAC) has wrestled with under REACH, as shown in this series of presentations , and which also presents a substantial challenge to plant protection products.
- “Frame formulations” provides greater flexibility for similar products to be authorised using the same data. The phrase “frame formulation” means “A group of biocidal products having similar uses and presenting specified variations in their composition [and containing] the same active substances of the same specification and where such variations do not adversely affect the level of risk of the efficacy of these products.” This is an important move away from the previous “one product one authorisation” approach, which meant that similar products differing only in their colour required separate authorisations! However, the same lengthy list of Product Types remains in the proposed Regulation, creating the potential for unnecessary re-evaluation of the same active substances.
- Register for Biocidal Products (R4PB) [Article 60]. The Commission will create and maintain this register, which will be used for information exchange between the authorities and for generation of application forms by applicants. This should substantially speed up and streamline the authorisation process.
- Data protection and, importantly, data sharing (particularly of vertebrate studies) will be encouraged in a way similar to that under REACH, and “free riders” will be forced to pay their way by 2015.
- Finally, the introduction of centralised authorisations for products could be an important improvement (analogous to the registration of pharmaceuticals). It is proposed that the European Chemicals Agency (ECHA )should take on responsibility for the central authorisation of biocides, starting with low-risk products and products based on new active ingredients from 2013 and extending to most other biocides from 2017. Experience of ECHA’s charges for and role in REACH Registration means that this idea causes concern to most in industry, and to at least some regulators in Member States.
In relation to dossier preparation for biocides, wca have experience in:
- Interpretation and robust study summary preparation (physico-chemical properties, environmental fate, analytical methods, toxicology, ecotoxicology
- IUCLID 5
- Assessing existing data to address data requirements (use of data in public literature, data gap analysis, (Q)SAR modelling, data waivers)
- Study placement and monitoring (liaison with contract laboratory, project management, review of protocols and results)
- Human and environmental risk assessment: (exposure routes & scenarios, exposure modelling, environmental hazard assessment and PNEC derivation, human health hazard assessment and AOEL or MOE and ADI or TDI derivation, risk assessment, MRLs where appropriate)
- Classification and Labelling of Products (physico-chemical hazards, mammalian toxicity hazards, ecotoxicity hazards, read-across)
wca have extensive experience in the preparation of regulatory reports under various pieces of legislation. Many staff members have formerly worked as regulators; this provides us with relevant insights into regulatory freedoms and constraints when discussing issues with the regulators at various stages of dossier preparation.
wca staff and Associates also have expertise in socioeconomic assessment, and are able to balance the risks and benefits of product alternatives.