Biocidal product regulations: What you need to know

Thousands of chemicals are used in the vast array of products available for domestic and business needs, such as household and industrial cleaning products, soaps and shampoos, cosmetics and deodorants, and paints and pesticides.

Regulations to protect humans, animals and the environment against poisoning and pollution from all these chemicals have been around longer than me. Many countries around the world have implemented different tiers of regulation to minimise risk.

Recently, there has also been a drive to harmonise the regulatory requirements among groups of countries to lower barriers to trade. There are many examples around the world where groups of countries have seen the benefits of agreeing to the same regulations (probably with varying levels of success), including:

• The EU Biocidal Product Regulation (BPR, EC 528/2012).
• Versions of the EU REACH (1) regulation in Korea (K-REACH) and China.
• A building block approach to implement versions of GHS(2) worldwide in countries including EU, New Zealand, Japan, Korea, Canada, Mexico, and Singapore.
• The NAFTA agreement between Canada, Mexico, and the USA has seen an effort being made to harmonise pesticide registration requirements in a trading block which has an estimated value of $17 trillion.
• New Zealand and Australia working together to harmonise labelling requirements for aerosol products and animal health products.

Achieving aims

1 September 2016 was a milestone deadline in the latest revision of the EU regulation controlling the supply and use of non-agricultural pesticides (also known as Biocides). It got me thinking about whether it is achieving its aims of improving the functioning of the biocidal products market in the EU while ensuring a high level of protection for humans and the environment.

With the passing of the deadline, I thought this would be an appropriate time to look at the history and evolution of the EU Biocidal Products Regulation (BPR), which first came into force over 16 years ago as Biocidal Products Directive 98/8/EC.

At 97 articles and 7 annexes, the new BPR certainly has high ambitions to raise the safety standard of biocide use in the European market.

Indeed, it is considered as the gold standard in biocide regulations worldwide, but there are concerns from industry about the cost burden for pursuing authorisation and the length of time it takes to complete.

A harmonised market, as far as it is possible to achieve, ensures the same high standards are applied across all member countries of the European Union. This also means that a product approved in one country will be accepted in all the other countries in the agreement.

The BPR attempts to streamline and speed up the authorisation process with the recent introduction of:

• the concept of the Biocidal Product Family Registration route;
• Mutual Recognition in Parallel;
• Same Biocidal Product;
• Union Authorisation; and
• Simplified Procedure.

Bigger companies have internal expertise and can collaborate with partners as a way of driving innovation. Working together with experts at all levels of industry and with the regulatory bodies will ensure products are safe, compliant and efficacious while still delivering innovative solutions for pest control.

Background to the Biocidal Products Directive 98/8/EC

The Biocidal Products Directive 98/8/EC established an authorisation scheme to ensure that active substances and biocidal products are assessed so that they are safe for people to use, and will not harm the environment, before they are placed on the market.

Prior to the Directive, each European member state applied their own national rules regarding the marketing of biocides. Some countries had very strict rules relating to marketing, eg The Netherlands had a national registration scheme for 22 of the 23 biocidal product types identified in the Directive, while other countries had a very simple scheme of notification for biocides and most regulated just a few of the biocidal products coming under the scope of the Directive.

The Directive 98/8/EC was in force from 13 May 2000 until 31 August 2013, after which it was reviewed and replaced with the Biocidal Product Regulation (BPR; EU 528/2012).

Definition of a biocidal product

A biocide is defined in Article 2(1)(a) of the Biocidal Product Directive (refined in the 2012 revision) as:

“Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.

Control by means of physical or mechanical action is excluded.

Aims

One of the aims of the Directive was to harmonise the European market for Biocidal Products and their active substances. A biocidal product authorised in one member state should also be authorised upon application in other member states unless there are specific grounds to derogate from this principle of mutual recognition.

Cited reasons could be climate differences or other local market conditions, efficacy concerns or similar. In practice, this means there will always be scope for some markets to exclude products authorised elsewhere in the EU.

Scope

The Biocidal Product Directive (98/8/EC) came into force on 13 May 2000 and covered 23 Product Types (PT) in four main groups: disinfectants, preservatives, pest control products and water treatment chemicals.

It includes the traditional pest control products such as rodenticides, insecticides and wood preservatives. But it also includes other weird and wonderful substances such as:

• PT22 embalming and taxidermy fluids;
• PT17 piscicides for the control of fish;  and
• PT9 fibre, leather, rubber and polymerised material preservatives (products for the control of microbial deterioration of leather, rubber, paper and textile products).

While the Directive included substances not previously covered under the pesticide regulations such as disinfectants, it specifically excludes those covered elsewhere eg agricultural pesticides, medicines, and cosmetics.

Of the original 23 product types in the Directive, Product Type 20 Preservatives for Food and Feedstocks was replaced with what was PT23 Control of Other Vertebrates, under the latest revision. So now there are only 22 product categories.

A full list of product types can be found on the European Chemicals Agency website.

Requirements

From 14th May 2000 new active ingredients and products containing them had to meet the criteria set out in the Directive before being allowed to be marketed in the EU.

It included data and studies relating to the safe use, storage, product performance, human toxicology, environmental toxicity studies, analytical and chemistry information, disposal considerations and labelling.

Existing products would remain on the market while they were being reviewed to bring them up to the standard as set out in the Directive. Originally the review of existing products was expected to take 10 years, but it has since been extended to past 2020.

The review of existing products that fall within the scope of the Directive is based on the potential risk of their continued use. Once the data has been reviewed, the member state responsible for the evaluation of the data will make a recommendation for inclusion or non-inclusion.  A non-inclusion decision results in a period of 180 days to withdraw the existing product from the market.

Statistics show only 58% of existing active ingredients were being supported through the Directive (3). Is it because the remaining 42% were unsafe? Some may not meet the new criteria for authorisation to market. However, there are also the commercial considerations relating to market size vs. level of investment.

Introduction of the Biocidal Products Regulation (BPR EC 528/2012)

Around 10 years after the Biocidal Products Directive came into force; it was reviewed and replaced with the Biocidal Products Regulation (BPR; EC 528/2012).

The Regulation contains a number of new procedures, including the following:

• Extension to the definition of a biocidal product to include:
  • New rules for regulation of Treated Articles;
  • New rules for in situ generation of biocides;
  • Revision of food feed derogations;
• Authorisation of so-called biocidal product families;
• Union authorisation for certain product types;
• Mutual recognition in parallel;
• Authorisation of “the same biocidal product”;
• Simplified authorisation procedure.

There were also new provisions for Parallel trade permits, data sharing and an attempt to harmonise the fee structure for applications.

The Biocidal Product Regulation has been in force in the EU since September 1, 2013. A lot of the changes are procedural, but the extension to the scope was important because it impacted industries that previously had no biocide-related obligations.

Some of the key changes under the revised Biocidal Products Regulation are summarised below.

Requirements for Treated Articles

A “Treated Article, according to Biocidal Products Regulation (BPR EC 528/2012), means any substance, mixture or article that has been treated with or, intentionally incorporates, one or more biocidal product.

The product is considered a Treated Article if the biocide is present only as a means to protect the article itself, for example:

• a carpet that is treated against moths only as a means to protect the carpet itself; or
• a preservative added to a water-based paint or adhesive to prevent deterioration.

If the biocide is present as a means not to protect the item, it could be considered a biocidal product. Such an example could be an addition of a disinfectant to an anti-microbial paint for use in a hospital environment.

Treated Articles had to comply with the Regulation from 1 September 2013.

Products already on the market before this date entered the review programme.  An application for the approval of the active substance for the relevant product type had to be submitted on or before 1 September 2016.

If they were not submitted by then, articles treated with such active substances may not be placed on the market after 1 March 2017.

Requirements for in situ generation of Active ingredients

The term in situ here refers to the production of active substances manufactured at the point of use, both with or without the use of other chemical substances (precursors).

These products were previously excluded from the Directive because there had been no such biocidal product placed on the market.

Examples of in-situ generated biocides are:

• ozone disinfection of waste water;
• active chlorine produced from seawater.

Existing products covered by this definition had to have an application for approval submitted under the Biocidal Products Regulation on or before 1 September 2016. The products could then continue to be marketed until the review was complete.

If an application was not submitted before this date, the active substances cannot be used or supplied after 1 September 2017.

Food-feed derogations

While there are some exemptions in the original Biocidal Product Directive for Biocides based on foodstuff, the subsequent Regulation clarifies the definition.

The agreed EU position is that food or feed which is placed on the market only as food or feed but which is used as an attractant/repellent would be outside the scope of the BPR.

An example would be using strawberry jam to attract wasps to a trap because the jam is primarily intended as a foodstuff. That is not to say foodstuffs are excluded from the scope of the Regulation. If the product is placed on the market intended only for repellent/attractant use, it would be within scope even if they consist entirely of food or feed.

Existing products on the market which met this new definition had to be notified to the European Chemicals Agency (ECHA) before 30 November 2015.

If a dossier was not submitted, existing stocks of the product have to be withdrawn by 30 October 2016.

Biocidal product families

According to the Biocidal Products Regulation, a biocidal product family means “a group of biocidal products having:

1. similar uses;
2. the same active substances;
3. similar composition with specified variations; and
4. similar levels of risk and efficacy.

The application must identify:

• the maximum level of risk;
• the minimum level of efficacy;
• permitted variations in composition and uses together with their respective classification;
• hazard and precautionary statements; and
• any appropriate risk mitigation measures.

Grouping products together in a family should minimise cost, and make the evaluation easier and faster.

Union Authorisation

The Biocidal Products Regulation (BPR) introduces the possibility to have certain biocidal products authorised at Union level. This will allow companies to place their biocidal products on the market throughout the entire Union, without the need to obtain a specific national authorisation.

There are strict conditions for union authorisation e.g. similar conditions of use across the Union and there are exclusions for certain biocidal product types and those active ingredients meeting exclusion criteria.

Mutual Recognition in Parallel

As a way of streamlining the authorisation process, it is possible to apply for all countries where you wish to market the Biocidal Product in Europe, at the same time. The Member State that evaluates the application shall agree on the conditions of authorisation together with all the other relevant (concerned) Member States.

Simplified Authorisation Procedure

The Simplified authorisation procedure allows products that meet certain conditions to be evaluated against more simple criteria. The conditions for eligibility include the requirement for all the active substances contained in the biocidal product to be listed in Annex I and satisfy any restriction specified in that Annex:

• the product does not contain any nanomaterials;
• the product does not require any personal protective equipment; and
• the product is sufficiently effective.

Same Biocidal Product

The BPR introduces the new concept of the Same Biocidal Product. It allows a faster and cheaper authorisation route for authorisation of the same biocidal products from the same company or other companies under the same terms and conditions.

How has the new BPR improved EU authorisation for biocides?

The aims of the revised Biocidal Product Regulation remain the same as the original Directive, but it has made significant improvements. With the introduction of:

• Streamlining: The revision has aimed to streamline the approval process by:
  • simplifying the approval of active substances;
  • simplifying authorisation of biocidal products; and
  • introducing timelines for Member State evaluations.
• Reduction of animal testing: It promotes reduction of animal testing by introducing mandatory data sharing obligations and encourages use of alternative testing methods.
• Online platform for applications: There is a dedicated IT platform, the Register for Biocidal Products (R4BP 3) and IUCLID for submission of applications and as a means to exchange information between the applicant, ECHA, Member State competent authorities and the European Commission.

It is positive that there is an attempt to streamline and harmonise the process for marketing biocides in the EU, but how successful this is, as the review programme progresses, remains to be seen.