The Regulation of Biocidal Products in Europe (Part II)

Union Authorisation

The new Regulation introduces the concept of Union Authorisation into the biocides authorisation process for the first time. Union Authorisation, as the name implies, is a product authorisation that is valid throughout the European Union and it confers the same rights and obligations in each Member State as a national authorisation.

Union Authorisation will not be available for all product types, with Product Types 14,15,17,20 and 21 being excluded from scope. This exclusion is also extended to those products that contain Active Substances that meet the exclusion criteria set out in Article 5 of the  Regulation  (substances that are for example mutagens, carcinogens and very persistent and very bioaccumulative) .

There will also be a phased approach to the availability of Union Authorisation. From the initiation of the Regulation on 1st September 2013 Union Authorisation will be available for Product Types 1,3,4,5, 18 and 19. Following on from this, Product Types 2, 6 and 13 become eligible for Union Authorisation from January 2017, and the remaining Product Types from January 2020. An important point is that Union Authorisation will only be available for those biocidal products that are similar in their intended use across the MS.

Union Authorisation is not intended to replace the current principle of Mutual Recognition between EU MS. Mutual Recognition will itself have some changes within the Regulation but will remain available – this is crucially important for, but not limited to, those products ineligible for the Union Authorisation process. The procedure for Union Authorisation is different to that of Mutual Recognition. The key difference is that Union Authorisation will be overseen by ECHA although the initial review and evaluation of applications will still be conducted by a Member State (chosen by the applicant). ECHA will provide an opinion on the suitability of the product for Union Authorisation and the EU Commission will make a decision on the placing of the product on the entire market of the European Union.

The expanded role of ECHA within the new Regulation

Under the old Biocides Product Directive the authorisation process for Active Substances was at EU Level and authorisation of Biocidal Products was the responsibility of individual MS, via their nominated Competent Authorities. This process survives the change to the new Regulation but is extended through the opportunity for Union Authorisation; overseen by the European Chemicals Agency (ECHA) as previously described. The change to a Regulation also brings about a change in the Authorisation Process. ECHA will take a leading role in the process and a new decision making committee will be established within ECHA – the Biocidal Products Committee.

ECHA and Active Substances

Under the new Regulation, companies now have to apply to ECHA, by submission of a dossier, for approval of Active Substances. This is a change from the process under the Directive, where the submission was made directly to a nominated MS Competent Authority. ECHA will be responsible for the validation check but a relevant Competent Authority will still carry out a dossier completeness check and evaluation. On completion of the work by the Competent Authority, the results of the evaluation are returned to ECHA where it is processed by the Biocidal Products Committee and an opinion on approval (or non-approval) of the substance is passed to the European Commission for the final decision.

ECHA and Biocidal Products

Once an Active Substance is approved, Biocidal Products based on that substance and placed on the market will require authorisation – this is Product Authorisation. Under the new Regulation, Product Authorisation may still be with an individual MS and, as previously found under the Directive, dossier submission is still made directly to a MS. The principle of Mutual Recognition, also found in the Directive, still remains but in a refined form. Therefore, once a product is authorised for use by a Member State, the applicant can ask for authorisation by other Member States, either in sequence (first in one MS, then in other MS) or in parallel (simultaneously in MS). The role of ECHA in the mutual recognition process is to act as initial co-ordinator in case of disagreement. Ultimately though, disagreement may be resolved by the European Commission, guided by ECHA.

A further key role that ECHA play in the product authorisation process is in managing the workflow through the Union Authorisation process as mentioned earlier.

Other changes of note

The Biocidal Product Regulation introduces the concepts of Alternative Suppliers and Technical Equivalence. It also introduces a change in the legal obligations regarding the sharing and protection of data. Alternative Suppliers will have to provide evidence of legal access rights to data.

In conclusion

The Biocidal Products Regulation introduces changes to a Directive to broaden the scope of regulation and reshape the EU procedures for active substance and product authorisation. It introduces centralisation and harmonisation that if applied flexibly by EU Authorities could bring benefits in saving both time and expense in authorising biocidal products.  On the other hand if applied rigidly are unlikely to improve the current slow and complex process of product authorisation.  It introduces the specific regulation of Nanomaterials and Treated Articles, but in doing so leaves something lacking in the definition of their terms – especially those applied to treated articles where claims associated with active substances and use of products raises uncertainties in defining scope under the Regulation.

Little has been made of the impact on industry of all the above. The use of a central agency comes at a cost and draft guidance on fees for product authorisations has now been publicized and shows for example that the cost to use ECHA for a Union Authorisation is likely to run into hundreds of thousands of Euros per product. Some savings may be available by exploiting the concept of Product Families but the financial barriers will remain significant.

These costs will have an effect on the shape of the market. Even in their largest form, Small to Medium Size Enterprises (SMEs) will find these costs hard to justify in the biocide market. Add to this the complex regulatory requirements involved in dossier submission and it becomes rapidly apparent that SMEs will have to develop strategies to allow them to survive. Just how they will do this is currently unclear but a degree of co-operation will almost certainly be required.

The European Commission is anticipating that the review and authorisation of biocidal products will continue well into the third decade of this century – it is easy to believe that they are being very optimistic.