ECHA

Legislation on biocides was designed to create a demand for safer alternatives by removing the most toxic substances from use. Substances have been restricted, but is there enough innovation underway? We mapped the measures that are already in place to support innovation in biocides.

Legislation-built demand

The most toxic active substances are not approved for use. This is to protect human and animal health, and the environment. A substance that, for example, has endocrine-disrupting properties or is classified as carcinogenic is not approved unless:

• it can be shown that the risk from exposure to it is negligible; 
• it is essential to prevent a serious danger to human or animal health or the environment; or
• if not approving it would have a disproportionate negative impact on society.

Didier Leroy. Image: ECHA.

“The paints industry selects substances for their best technical, efficacy, toxicological and cost profiles,” says Mr Didier Leroy, Technical Manager at the European Council of the Paint, Printing Ink and Artists' Colours Industry (CEPE). “Restricting any of the substances in legislation clearly leads to a need to substitute them with options that have a better ‘regulatory profile’. Nowadays, regulatory pressure is a key driver for substitution, but sometimes there are no suitable alternatives available.”

As an example of substitution, Mr Leroy mentions the EU’s Paints Directive that concerns emissions of volatile organic compounds from decorative paints. “In my own industry, 85 % of decorative paints are now water-based thanks to the legislation. But, water-based paints need preservatives to survive, and this is where our need for biocides comes in.”

As a downstream user, Mr Leroy says the predictability of authorities’ decisions on substances could be improved, as this would allow companies to better adapt their business. “For better predictability, we would like to see the authorities evaluate and give their outcome on substances for particular uses in batches, by product-type. This way, they could take a weighted decision in the end to make sure that sufficient tools remain available to preserve products.”

Predictability would also help companies decide whether to invest in research and innovation, Mr Leroy stresses. “If the outcome of a big investment and years’ of development work is not certain, companies might be reluctant to act on new ideas.”

So far, out of 246 fully assessed dossiers, 236 active substances have been approved at EU-level for different product-types, like disinfectants, preservatives and pest control products. In 10 cases, substances have not been approved.

Customer-built demand

From a customer’s point of view, innovation is needed. “We see a continuous reduction in available solutions for preserving our products,” Mr Leroy underlines. “Substances are starting to be dropped from the market because they have not been approved for use, but at the moment we see little innovation taking place and few new solutions being developed to replace them. There is a clear demand for new biocides, or even solutions not involving any biocides.”

“As a downstream user, we rely on manufacturers to obtain our substances, and there are not that many biocides suppliers on the market,” Mr Leroy says. He explains that it is not easy for companies to enter the biocides market without any previous knowledge and financial support. “Smaller companies are interested, but they need more guidance on how to manage the legal processes,” he adds.

Consumer-built demand

Consumer pressure to find less harmful options is growing. During 2018, ECHA will be working to make its database on biocidal products more user-friendly. Citizens will have access to more data on biocides than before. For example, you can pick up a biocidal product in a shop and search the database with the name on that product. You will see who holds the authorisation and in which EU countries. You will also be able to compare the product with others to find options that might be more favourable to health and the environment.
 

Where to look for alternatives

Active substances that could cause concern are identified on an ongoing basis as candidates for substitution. The EU system for biocides has steps in place to encourage replacing these substances, and products containing them, with more favourable options.

Before substances that are identified as candidates for substitution can be approved for use, a call is launched on ECHA’s website to find alternatives. So far, there have been 35 such calls for information.

If no alternatives are found, these substances can be approved, but the decision will have to be re-evaluated in seven years’ time at the latest. The list of candidates for substitution is therefore a good place to start when looking for areas where innovation is needed.

For biocidal products, the EU system has also added an extra step. If a biocidal product contains an active substance of concern, it can be authorised for use only after the authorities have looked for alternative products on the market. If more favourable alternatives exist, the use of the product can be prohibited or certain uses can be restricted.

If there are new or lesser-known alternatives available on the market, ECHA’s public calls for information are the perfect opportunity to let authorities and companies know about them.

Looking for incentives?   Apply for funding   Have you considered applying for funding to help your research? Several options are available both at EU and national level. There are two grant types you can explore: grants for substitution and innovation or loans and guarantees adapted to the needs of small and medium-sized companies. The EU’s Horizon 2020 programme is funding projects in the field of biocides. With a quick search in their database, you can find hundreds of projects. To help you get started, contact your local Enterprise Europe Network (EEN) partner, who will be able to consult the network’s database for offers in more than 50 countries. Fast-track to the market Does your product contain a new active substance? You can fast-track to the EU market even though your substance has not yet been approved. You can be granted a provisional, three-year authorisation to access the entire EU market. This can be extended for one additional year. A requirement is that the EU country currently evaluating your substance gives a recommendation for approval for the substance. Get a simpler authorisation Does your product contain an active substance that is more favourable for health and the environment? You are entitled to simpler authorisation. This means your application is processed faster and there is less bureaucracy involved. Your product can be made available in all EU countries by simply notifying the relevant countries’ authorities. No applications are needed. To get this simpler authorisation, your product can only contain active substances that are considered less harmful. These substances are listed in Annex I to the Biocidal Products Regulation (BPR). Protect your innovation Invested time and money in developing a new active substance or product? It might be important for you that the data is kept confidential. As an incentive for developing new substances and products, longer periods of data protection are granted. When you apply for the approval of an existing active substance, the data on your substance will be protected for 10 years. For a new active substance, the period of data protection is extended to 15 years. The same applies to products containing a new active substance. When you apply for an authorisation for a product that contains a new substance, the data you provide will be protected for 15 years.

Further information:

Guide for small companies

Candidates for substitution

Approval of active substances

Authorisation of biocidal products

SUBSPORT - platform for information, tools and guidance on alternative substances and technologies

Horizon 2020 funding opportunities

Enterprise Europe Network

Interview by Veera Saari

Top image: © IStock.com/Roksana Bashyrova

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