The Acta Group will conduct a webinar on Biocidal Product Regulation on September 19, 2012.
On May 22, 2012, the European Union (EU) adopted the Biocidal Products Regulation (EC Regulation 528/2012) (BPR), which will replace and repeal the Biocidal Products Directive (BPD) (98/8/EC) currently in effect for regulating biocidal active substances and biocidal products. The BPR entered into force on July 17, 2012, with many new provisions going into effect on September 1, 2013, with a transitional period for certain provisions. The BPR is available online. Pesticides in the EU are divided into two major groups: (1) “plant protection products,” which mainly encompass agricultural pesticides; and (2) “biocidal products,” which is the EU term for antimicrobial pesticides. The BPR only affects biocidal products and the active substances contained therein. While the BPR and BPD have similarities, including in particular the two-step authorization process, there also are several important changes, including the scope of products, data generation requirements, and the data compensation framework. These issues are outlined below.
BPR Scope
The BPR defines active substances and biocidal products as follows:
- “Active substance” is defined as “a substance or a micro-organism that has an action on or against harmful organisms.”
- “Biocidal product” is defined as:
- any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,
- any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
- any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,
BPR Article 3(a), (c). The inclusion of the term “treated article” (defined as “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products” (BPR Article 3(l)) in the definition of biocidal product is significant as it extends the scope of products subject to BPR to include articles and materials treated with biocidal products. Treated articles such as wood treated with anti-fungal active substances (where the intention is only to control organisms within the wood with no expected release) were not previously subject to authorization under the BPD. Authorization under the BPR thus may provide a challenge to industry as many of these products were previously exempt from authorization under the BPD.
Nanomaterials
Also significant is the new definition of “nanomaterial,” defined as:
a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm.
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.
BPR Article 3(z). In addition, for the purposes of the definition of nanomaterial, “particle,” “agglomerate,” and “aggregate” are defined as follows:
— “particle” means a minute piece of matter with defined physical boundaries,
— “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components,
— “aggregate” means a particle comprising strongly bound or fused particles.
BPR Article 3(z). The BPR specifies that any approval of an active substance “shall” not cover nanomaterials except where explicitly mentioned. BPR Article 4(4). When evaluating nanomaterials in a biocidal product application, one of the conditions for granting an authorization is that “where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.” BPR Article 19(1)(f). Nanomaterials are not eligible for the simplified authorization process as discussed below.
Approval of Active Substances
As in the BPD, the approval of active substances takes place at the Union level. Several categories of substances are excluded from being approved, including carcinogens, mutagens, and reprotoxic substances category 1A or 1B according to the CLP Regulation; endocrine disruptors; persistent, bioaccumulative, and toxic (PBT) substances; and very persistent and very bioaccumulative (vPvB) substances. BPR Article 5. The BPR sets forth the procedures under which applications are submitted, validated, and evaluated, which can take up to two years to complete. BPR Articles 4-11. The European Chemicals Agency (ECHA) will provide the administrative duties concerned with community level substance approvals, however, assessment and approval of active substances will still be completed by an EU Member State Competent Authority (CA). The European Commission (EC) makes the final decision based on the evaluation and opinions submitted by ECHA and the CA whether to adopt an implementing Regulation providing that an active substance is approved. BPR Article 9.
Authorization Approval Types
For active substances that have been approved at the Union level, companies must also seek approval for the biocidal products containing those active substances at the Member State level. Importantly, there are now possibilities for some biocidal products to be authorized at the Union level and thus direct access to the entire Union market. The key authorization procedures for biocidal products under the BPR are discussed below.
Simplified Authorization Procedure
Biocidal products containing only active substances included in Annex I of the BPR are eligible for the simplified authorization procedure, provided that the product does not contain any “substance of concern” or nanomaterials, the product is “sufficiently effective,” and the “handling of the biocidal product and its intended use do not require personal protective equipment.” BPR Article 25. Simplified authorizations shall be evaluated within 90 days of receipt of the application. BPR Article 26. A biocidal product authorized in accordance with this simplified procedure may be made available on the market in all Member States without the need for mutual recognition. The authorization holder must notify “each Member State no later than 30 days before placing the biocidal product on the market within the territory of that Member State and shall use the official language or languages of that Member State in the product’s labelling, unless that Member State provides otherwise.” BPR Article 27. Annex I of the BPR currently includes only 19 substances so the use of this simplified authorization process will be limited, although the BPR does set forth the procedure to add substances to Annex I.
National Authorization of Biocidal Products and Mutual Recognition
Biocidal products which are not yet subject to community level approval through ECHA must be authorized at the Member State level and then can be the subject of mutual recognition. The authorization of biocidal products at the Member State level is a lengthy process. A CA has 30 days, from receipt of delivery, to validate the application based on a determination that the relevant information has been submitted and “the applicant states that it has not applied to any other competent authority for a national authorization for the same biocidal product for the same use(s).” BPR Article 29. The CA then has 365 days from the validation date to evaluate the application. BPR Article 30. After a Member State authorizes a biocidal product to be placed upon the market within its jurisdiction, there are two systems of mutual recognition available under the BPR. Mutual recognition can be sought from other Member States either while the initial application is being processed (mutual recognition in parallel) or after the initial Member State has granted an authorization (mutual recognition in sequence). BPR Articles 33-34. The mutual recognition system is still very complex under the BPR; each Member State must review the assessment report of the initial Member State, and reach its own conclusions as to whether the product should be authorized, and if restrictions should be put in place.
Union Authorization of Biocidal Products
One of the new elements included in the BPR is the possibility of having certain biocidal products authorized at the Union level. Applicants may seek “Union Authorizations” for biocidal products that “have similar conditions of use across the Union,” although biocidal products containing certain active substances excluded from approval under Article 5 and certain product types are not eligible for Union Authorization. BPR Article 42. Union Authorization will be available in three different stages depending on the product type:
- From September 1, 2013: Product types 1 (Human hygiene), 3 (Veterinary hygiene), 4 (Food and feed area), 5 (Drinking water), 18 (Insecticides, acaricides, and products to control other arthropods), and 19 (Repellents and attractants);
- From January 1, 2017: Product types 2 (Disinfectants and algaecides not intended for direct application to humans or animals), 6 (Preservatives for products during storage), and 13 (Working or cutting fluid preservatives); and
- From January 1, 2020: All remaining product types except 14 (Rodenticides), 15 (Avicides), 17 (Piscicides), 20 (Control of other vertebrates), and 21 (Antifouling).
While the application is submitted to ECHA, an EU Member State CA must agree to review and evaluate the application and forward its results to ECHA, which has 180 days to prepare an opinion. The EC makes the final decision based on the evaluation and opinions submitted by ECHA and the CA whether to adopt an implementing Regulation granting the Union Authorization of the biocidal product. BPR Article 44(5).
Data Sharing and Protection
A key change in the legal obligations for the authorization of active substances and biocidal products is the procedure regarding the protection and sharing of data. Previously, under the BPD, if the active substance was already authorized for a particular product type, companies that did not own or share in the data supporting the authorization of the active substance could market biocidal products of the type authorized that contain the active substance. This is no longer the case under the BPR. Instead, the BPR provides that:
data submitted for the purposes of the [BPD] or of this Regulation shall not be used by [CAs] or [ECHA] for the benefit of a subsequent applicant, except where:
(a) the subsequent applicant submits a letter of access; or
(b) the relevant time limit for data protection has expired.
BPR Article 59(1). The time period of data protection 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. BPR Article 60.
In addition, with regard to animal testing, the BPR includes a procedure to ensure companies can no longer repeat 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. If such a study exists, ECHA must provide the applicant with information regarding the data submitter and owner. If the data are still protected, “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.” BPR Article 63(1). The parties also could submit the matter to an arbitration body and commit to accept the arbitration order. Although these procedures are not required for non-vertebrate studies, an applicant could choose to ask ECHA whether any non-vertebrate studies have been submitted, and, if such studies exist, the parties must make every effort to reach an agreement.
If an agreement is reached, the applicant will be provided copies of the data at issue or given permission to refer to the data as set forth in a letter of access. If no agreement is reached, the applicant must inform ECHA, who 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.” BPR Article 63(3). Compensation for data sharing shall be determined in a “fair, transparent, and non-discriminatory manner,” which is the same standard for determining compensation under REACH. BPR Article 63(4). 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.” BPR Article 63(3).
This change in data ownership requirements will place additional financial costs upon potential applicants and is considered to be fairer because it spreads the cost of authorization of the active substance across all companies placing that active substance upon the EU market. ECHA and the EC have previously indicated that guidance documents on data sharing will be provided on ECHA’s website for use by data holders and potential applicants. ECHA has also indicated that data sharing disputes will be handled in a similar manner to those occurring under REACH.
Conclusion
The BPR is now law in all EU Member States. It does not require Member States to take action themselves to implement the legislation. The approval process for biocidal products has varied across the EU based upon each Member State’s interpretation of the BPD, since EU Directives are proposed and adopted into the legislation framework of each EU Member State. Because the legal form for procedures related to biocides has now changed, it is expected that the BPR will establish a more harmonized and fairer authorization system for the authorization of biocidal active substances and products within the EU. The addition of Union Authorization procedures also is expected to simplify the process of taking a product to market and greatly reducing the costs of doing so.
To avoid the level of confusion experienced when REACH entered into force, ECHA and the EC must release supplementary guidance as soon as possible to ensure that potential applicants are aware of all requirements and obligations placed upon them. ECHA’s involvement and authority in resolving data disputes under REACH has thus far been ineffective, so this is one area in particular when guidance will be critical. The change in the legal obligation that all treated articles must now be authorized prior to placing upon the market in the EU will mean that a number of biocidal products currently supplied to the EU will need to be authorized or withdrawn from the market.