The Regulation of Biocidal Products in Europe (Part I)

Introduction

Biocidal Products and the Active Substances contained in them have, in Europe, been subject to varying degrees of control for a number of years. This was harmonised over a decade ago by the bringing into force of the Biocidal Products Directive (Directive 98/8/EC). Recent activity has seen the repeal of the Biocidal Products Directive in favour of the Biocidal Products Regulation  (Regulation (EU) 528/2012), the aim of which is to further improve the functioning of the biocidal products market in the EU, whilst ensuring a continued high level of protection to both humans and the environment.

The proposal for the new Regulation was agreed in 2009 and the text adopted in May 2012. The Regulation applies from the 1st September 2013.

What does this change mean?

Firstly it is important to understand that much of what was found in the former Directive remains, albeit not always exactly the same. However, the change to a Regulation brings with it some major revisions in the form of significant additions and some minor but important alterations.

The most significant changes are the addition of articles covering the inclusion of Nanomaterials and the bringing into scope of Treated Articles for the first time. There are also some subtle changes in the scope of the Regulation which introduces the potential for dual regulation (regulation under 528/2012 and other applicable EU regulations depending on the use and claims made for a product).

Also significant is the increased role that the European Chemicals Agency (ECHA) will play in the process of authorising biocidal products and in overseeing a new concept of Union Authorisation. Submissions for active substance and product authorisation will be made using a dedicated IT platform, the Register for Biocidal Products, which will be the principle tool for monitoring product authorisations and disseminating information relating to products between Member States (MS).

There are several changes that are less prominent than the more obvious differences found above. These include for example provision for the regulation of alternative suppliers and the assessment of technical equivalence. Some changes are very subtle, but give their subject more prominence. One of these changes is the move from Frame Formulations to Product Families. Product Families may offer an opportunity for reducing the burden of cost if applied flexibly by MS.

The major additions

As mentioned earlier, the two major additions are those of Nanomaterial and Treated Articles, either of which were either absent, poorly defined or considered out of scope of the original Directive.

Nanomaterial

The Regulations introduce, for the first time when applied in a biocidal context, a harmonised definition of what is meant by nanomaterial.

This is:-

"Any 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 1nm to 100nm.”

The Biocidal Products Regulation approaches nanomaterial in the following ways.

The approval of an active substance shall not cover nanomaterial except where explicitly mentioned.

When test methods are applied to nanomaterial, an explanation shall be provided of their scientific appropriateness for nanomaterial, and where applicable, of the technical adaptation/adjustments that have been made in order to respond to the specific characteristics of the nanomaterial.

All nanomaterial incorporated into a biocidal product shall be subject to labelling identifying it as such.

Treated Articles

Under the new Regulation, Treated Articles will be brought into scope. The key principle being that a Treated Article shall not be placed on the market unless all Active Substances contained in the biocidal products that it was treated with, or it incorporates are included on the Union Approved List of Active Substances for the relevant Product Type and that any specified conditions are met.  The Union List of Active Substances contains those substances that have been reviewed at EU level and are accepted as being safe for use in biocidal products.  The Union List is similar to Annex I of Directive 98/8, which it will replace.

Where a claim is made regarding the biocidal properties of a Treated Article then there will be labelling requirements as a condition of approval. These will include, but are not limited to, the Active Substance, the property attributed to the article, a statement on the inclusion of nanomaterial (if appropriate) and, where appropriate, relevant instruction for the use of the article.

There is an element of consideration, when necessary, to include any measures necessary for the use of the Treated Article to protect public health and the environment.

Also there is a requirement in the Regulation that relevant information must be provided to consumers free of charge, within 45 days of a request for such information being made.