The European Union (EU) Biocidal Products Regulation (BPR) has entered into EU law. This legislation changes the way in which biocidal active substances and biocidal products are regulated in the EU. The new EU regulatory system differs from other global regulatory systems for biocidal substances and redefines what are considered biocidal products and treated articles. Companies competing in this space must be aware of and careful to ensure that existing supply chains and biocidal product designs are in compliance with the new regulation and anticipate what will be the new normal.
The new EU BPR (EC Regulation 528/2012) entered into force on September 1, 2013, amid widespread controversy and confusion within the chemical industry. Issues arose due to several changes from the BPR's predecessor, the Biocidal Product Directive (BPD), that are, for the most part, addressed in the BPR. The BPR fully replaces the BPD and, as such, changes in the scope of the regulation have inspired industry concern. Under the BPR, all companies placing biocidal active substances or biocidal products on the EU market must share proportionally the burden for pursuing the approval or authorization process. Downstream users and customers of such companies are not required to share in the cost burden of authorization approval, however, the increased regulatory requirements and cost may ultimately be passed onto downstream users via cost increase in obtaining biocidal substances and products.
Biocidal active substances and biocidal products are defined as any neat substance or product (which may include articles) that exerts an effect on harmful organisms. This 'effect' is expansively defined to include anything, including destruction, deterrence, rendering harmless, or preventing the action.
Regulation of Biocidal Substances and Biocidal Products
Biocidal substances and biocidal products are produced by many industry sectors, some of which traditionally may not be thought of as biocidal products in other jurisdictions.
The Product-Type 6 'preservatives for products during storage' is illustrative of how the EU BPR can differ from other global regulations in that biocidal active substances added to products purely for the purpose of in-can or in-storage preservation are often exempted in other jurisdictions, but are regulated in the EU. This can cause great confusion for non-EU manufacturers that intend to have their products imported into the EU. Care must be taken to ensure that the substance is approved for this use, and that permission is obtained from the approval holder prior to commencement or continuance of import.
Impact on Biocide Registrants and Downstream Users
Due to the changes in regulation and the new provisions included in the BPR, many industry sectors will experience first hand the impact of the BPR adoption. Impacts may be purely financial, where companies will need to obtain authorization to refer to an existing approval or authorization, or may require additional resources and administrative burdens. For example, companies wishing to continue importing products or materials that were not previously regulated will need to arrange for this to happen, which will take time and money. The most common impacts on industry are broken down into the following sections.
Recognized Suppliers List
The most significant impact on industry is likely to be the inception of the 'recognised suppliers list.' This is a list of all suppliers of biocidal active substances that have contributed to the cost of the active substance approval and is maintained by the European Chemicals Agency (ECHA). Starting on September 1, 2015, only biocidal products containing active substances supplied by a recognized supplier (on the recognized suppliers list) can be legally placed upon the EU market. Supply chains could be impacted while current suppliers of biocidal active substances determine whether to join a cost sharing agreement and thus be included on the recognized suppliers list, or to cease supply to the EU if this is not financially viable.
Access to the approval or authorization (through a cost sharing agreement) is only granted where the identity of the active substance is shown to be 'technically equivalent' to the active substance that has already been assessed and approved. The technical equivalence assessment is conducted by ECHA in a two-tiered manner.
- The first tier consists of a basic comparison of the physical and technical parameters of the reference substance to the active substance being assessed. In most cases, the assessment is expected to conclude with a decisive yes or no conclusion.
- The second-tier assessment is conducted when the Tier One evaluation results are inconclusive. This assessment is based upon the toxicological and ecotoxicological information available on the reference substance and the active substance to be registered. Testing on vertebrate animals may not be conducted for the purposes of technical equivalence.
The technical equivalence assessment is required whenever the manufacturing process or manufacturing site of the active substance is changed.
The BPR regulates 'treated articles' in a similar way to biocidal products. Treated articles are defined as any substance, mixture, or article that has been treated with, or intentionally incorporates, one or more formulated biocidal products or biocidal active substances. Some examples of treated articles are a wooden bench painted with a wood preservative, and clothing treated with biocidal substances to reduce microorganism growth or odors. Items with multiple components become treated articles when one or more components are treated with or incorporate a biocide; an example of this would be a sofa where the wooden frame has been treated with a wood preservative.
Companies importing treated articles must ensure that all the active substances for which the article is treated, or incorporated, are approved for the relevant product-type. In the example of the sofa above, the active ingredients in the wood preservative would need to be approved for Product-Type 8 'wood preservatives.'
Companies must ensure compliance for the substances they manufacture or purchase from suppliers in the manufacture of their products. The first step to ensure compliance is to seek confirmation from each manufacturer or supplier of the presence of any biocidal substance(s). If the product or article contains a biocidal substance, the manufacturer or supplier also should provide certification or written assurance that all biocidal substances and products are approved or authorized. If this is not forthcoming, or if the manufacturer/supplier does not possess an approval for the substance and related use, then the company must determine whether to change suppliers to a manufacturer that can provide the approval, pursue the regulatory requirements itself, or stop manufacture of such products.
The formulation and processes used by the manufacturers are typically considered confidential business information, and as such there may be considerable reticence or reluctance to share this information with downstream users. In this case, the manufacturer may be able to provide written certification that all biocidal substances and products/articles contained in its products are suitably approved or authorized, without stating the specific and confidential information. This allows downstream users to proceed in good faith that the products they receive are suitably regulated. Whether a company can reasonably rely on such a certification can depend on several factors (e.g., the size and reputation of the company providing the certification, whether the company expresses a proficiency in BPR requirements).
To facilitate and expedite inspections by EU Member State agencies, companies must maintain records (electronic or hard copy) of manufacturing processes, quality assurance of products and batches, and information on safety of products (including any recall notices as applicable). As a minimum, the following documents must be kept and recorded:
- Safety Data Sheets (SDS) and specification of active substances and other ingredients used in product manufacture;
- Records of substance or product manufacturing operations;
- Results of internal quality control; and
- Identification of production batches.
For manufacturers of active substances or products, production batch samples also must be kept under appropriate storage conditions.
SDS for active substances and products must be created in the format specified in Annex II of the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation (1907/2006), amended by EU regulation 453/2010. SDSs must be provided to downstream users free of charge, either at the time of supply or beforehand. Many companies prefer to provide the SDS in electronic format. Importantly, however, many EU authorities have also expressed a wish to obtain a physical hard copy of the SDS in the appropriate language to accompany the shipment.
Enforcement and Penalties for Non-Compliance
Enforcement of the BPR is devolved to local and national agencies in each EU Member State, and is enforced under national laws. As an example, the UK has a fairly straightforward approach to enforcement, but this may not be the case with all EU Member States. In the UK, the BPR is enforced by the Health and Safety Executive (HSE) for issues arising from the use of biocidal products, and the local Trading Standards office for issues with retail and advertising. The BPR is enforced under the Health and Safety at Work etc Act 1974 (HASWA) in-line with the Health and Safety (Enforcing Authority) Regulations 1998 (SI 1998 No 494). Any breach of the BPR is enforced and prosecuted under HASWA by the HSE.
The maximum penalties are set out in Regulation 32 of The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013:
- on summary conviction -
- in England, Wales and Northern Ireland, imprisonment for a term not exceeding three months or a fine not exceeding the statutory maximum [(£5000)], or both;
- in Scotland, imprisonment for a term not exceeding twelve months or a fine not exceeding the statutory maximum [(£5000)], or both; and
- on conviction on indictment; imprisonment for a term not exceeding two years, or a fine or both.
Data Compensability under the BPR
The time period of data protection under the BPR varies from five to 15 years depending on whether the data support a new, existing, renewal of, or amendment for an active substance or biocidal product. The trigger for all data protection periods in all cases is 'when [the data] are submitted for the first time.'
Interestingly, the BPR does not set forth any time periods for which data are subject to 'exclusive use.' This differs from other regulatory regimes, for example, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(1)(F)(i), which sets forth the criteria under which data submitters can receive a ten-year period of exclusive use for certain data submitted in support of a registration for a new pesticide chemical or new uses of an already registered pesticide. Thus, during the ten-year exclusive use period, no other registrant is authorized to rely on data afforded exclusive use protection without the original registrant's explicit consent. Without a similar provision, the BPR does not provide any patent-like protection for companies that develop data for new active substances, new biocidal products, or new uses for biocidal products.
Mandatory Data Sharing and Compensation
The BPR includes a procedure to ensure that companies cannot duplicate tests that have already been performed on vertebrate animals. Instead, any applicant intending to perform a study involving vertebrates must submit a written request to ECHA to determine if such a study has already been submitted. Although not mandatory, an applicant also may submit a written request to ECHA to determine if any studies not involving vertebrates have been submitted. If such a study exists, ECHA will provide the applicant with information regarding the data submitter and owner.
If the data are still protected, the prospective applicant '(a) shall, in the case of data involving tests on vertebrates; and (b) may, in the case of data not involving tests on vertebrates, request from the data owner all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications.'
The prospective applicant and data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant. The parties also may submit the matter to an arbitration body and commit to accept the arbitration order. Unlike FIFRA, the arbitration procedure appears to be a voluntary option available to parties instead of making every effort to negotiate and reach agreement. Although these procedures are not required for non-vertebrate studies, if an applicant chooses to ask ECHA whether any non-vertebrate studies have been submitted and such studies exist, the parties must make every effort to reach an agreement regarding non-vertebrate studies as well.
If an agreement is reached, the data owner will provide the applicant with copies of the data at issue or give permission to refer to the data as set forth in a Letter of Access (LoA). The LoA must include:
- The name and contact details of the data owner and beneficiary;
- The name of the active substance or biocidal product for which access to the data is authorized;
- The date on which the LoA takes effect; and
- A list of the submitted data to which the LoA grants citation rights.
If an LoA is later revoked, such revocation shall not affect the validity of the authorization issued on the basis of the LoA in question.
If no agreement is reached, the applicant must inform ECHA and, within 60 days of being so informed, ECHA can give the applicant permission to refer to the requested vertebrate studies, provided that the applicant demonstrates that every effort has been made to reach an agreement and the prospective applicant has paid the data owner a share of the costs incurred.
This is similar to FIFRA to the extent that EPA is likewise allowed to rely upon studies submitted to it even if no compensation agreement has been reached. Compensation for data sharing shall be determined in a fair, transparent, and non-discriminatory manner. Although the data owner cannot refuse to accept any payment that is offered by the applicant, such acceptance is without prejudice to the data owner's right to have the proportionate share of the cost determined by a national court. Thus, the BPR provides for national courts, rather than arbitration bodies, to determine compensation when there is a dispute.
As noted above, under the BPR, companies must obtain authorization for the biocidal products and/or approval for the biocidal substances for which they place upon the EU market. Under the prior BPD scheme, companies could market in the EU any active substance or product already approved or authorized, respectively. This means that the cost of placing biocidal active substances and biocidal products on the EU market will increase due to the need for all entities to purchase an LoA to cite the data contained in the existing approval or authorization.
The LoA (the document that reflects the permission to refer to a particular dossier and/or specific data referenced therein) is estimated to be significant in cost with a range of several thousands to several tens of thousands Euros. In some exceptional cases (e.g., a small number of data sharers, a high cost for data to support the registration), the cost of the LoA may be much higher, reaching several hundred thousand Euros. The cost is calculated based on the cost of the data incurred to support the authorization or approval, which may include various sources of data, including potential new testing. The data compensation scheme can include additional costs that allow for inflation, risk, and administrative fees. The LoA fee can also include compensation for the time spent on the authorization or approval, by the dossier owner, as well as an additional charge for calculation of the LoA cost and any time spent by the dossier owner for the BPR regulation activities. The total cost of producing the dossier and obtaining the approval or authorization is then shared between all potential registrants. The method of calculating the total cost and individual LoA cost is varied as particular data compensation schemes are not prescribed in the Regulation. ECHA and the Regulation do, however, require that the LoA cost be determined in a fair and transparent manner.
Assistance with Compliance and Biocides Registrations
Companies not familiar with biocide registrations, data development, or data sharing negotiations, and the administrative burdens placed upon industry by the BPR, are likely to require assistance to ensure compliance and fulfill their regulatory obligations.
The Acta Group (Acta), an affiliate of Bergeson & Campbell, P.C., has experience assisting companies with biocides regulatory and compliance issues. Due to the similarity between the requirements of the BPR and EU REACH, experience of the technical and administrative aspects of EU REACH will be critical to these aspects of the BPR. Acta's experience with the EU REACH regulation will ensure that issues with SDS and technical equivalence can be dealt with in a simple and straightforward manner. Acta has also assisted companies with data sharing and compensation negotiations and settlement under REACH and FIFRA. Acta will be pleased to assist with organizing chemical inventories and obtaining information on outstanding regulatory obligations.
The dossier submission system used by the BPR will be IUCLID 5, which must be submitted electronically to ECHA using the Regulation for Biocidal Products (R4BP) Internet system. Acta has many years of experience in using the IUCLID 5 system to create dossiers and can also create, submit, and manage dossier submissions for clients using the R4BP system.