- Second REACH registration deadline a success
- Nearly 3 000 more substances registered by industry
- REACH 2013 - From our stakeholders
- Explaining REACH: Restricting substances – how is it done?
- Fair sharing of costs for active substance approval
- New biocides guidance coming
- From an exchange platform to providing practical solutions
- What do exposure scenarios look like in reality?
- Promoting substitution under REACH, CLP and the Biocidal Products Regulation
- Monitoring the effectiveness of enforcement
- Setting scientific principles for sediment risk assessment
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Promoting substitution under REACH, CLP and the Biocidal Products Regulation
The main objective of the European chemicals legislation is to ensure protection of human health and the environment both for present and future generations while ensuring a smooth functioning of the internal market as well as competitiveness of the European chemical industry. Substitution of harmful chemicals with safer alternatives plays an important role in achieving this objective. What is ECHA's role in promoting substitution? ECHA Newsletter reports.
"When people talk about substitution of hazardous chemicals, they often refer to authorisation of substances of very high concern (SVHCs). Of course, that is important, and in line with the SVHC roadmap to 2020 we will work hard on getting all the relevant SVHCs on to the Candidate List, but it's not the complete picture. The whole system of REACH, CLP and the new Biocidal Products Regulation (BPR) is built towards substituting dangerous chemicals with safer ones," says Jack de Bruijn, ECHA's Director for Risk Management.
The objectives of REACH and CLP will be achieved through better knowledge on the properties and uses of chemicals, which results in e.g. safer use and reduced exposure; and through using safer alternatives to substances of very high concern. "The key drivers for substitution under REACH and CLP are registration, information in the supply chain, authorisation and restrictions," Mr de Bruijn explains.
‘Getting to know your chemicals'
Registration is not just about submitting a dossier to ECHA and receiving a registration number to be able to do business on the EU market. It is more about the collection, generation and assessment of hazard and exposure data, risk assessment and the identification of risk management measures to ensure the safe use of chemicals.
"The registration obligation forces industry to systematically gather data according to the information requirements of REACH, analyse the data and decide on the right classification and labelling. During that process, companies might identify all kinds of issues which they may have missed before. Industry is getting more aware of what they are producing, using and placing on the market and, in some cases, may come to the conclusion that using a certain chemical is no longer desirable. For instance, a manufacturer may have discovered a less hazardous substance for a particular use and advises his clients against using the ‘old'. Collecting data and taking stock of what you have - that's the most important part of registration," says Jack de Bruijn.
Downstream users, on the other hand, have an obligation under REACH to check the instructions for handling and use of chemicals in the exposure scenarios that are provided by the supplier's (extended) safety data sheets.
"This obligation is new under REACH. Downstream users should check that they are using a chemical in line with what has been recommended to them. In some cases, they might realise that the recommendation does not make sense or that it is less stringent than what they are actually implementing. The idea of systematically going through risk management will make people ask themselves: Do I really want to use this dangerous substance and bear the consequences of the risk management measures or could I ask my supplier for a better alternative?" Mr de Bruijn says.
The increased and improved information on the classification and labelling of substances will also help companies to make better informed choices towards using safer substances.
"Another important aspect in promoting substitution is the need for article producers to communicate whether their articles contain SVHCs included in the Candidate List. This may trigger requests from retailers to phase out SVHCs in articles, and also enables consumers to make informed purchasing decisions."
Substitution already happening
Authorisation of hazardous chemicals aims to ensure that risks from SVHCs are properly controlled, and that these substances are progressively replaced with safer alternatives. Companies have the opportunity to apply for an authorisation to continue (or to start) using a hazardous substance. This application has to include an analysis on the availability of alternative substances or techniques, and is subject to a public consultation, where more information on substitutes might become available.
"Clearly substitution is happening. For example, the application deadlines for musk xylene and MDA were in February 2013 and we did not receive any applications. Apparently, the companies using these substances have decided to replace them and they are no longer used in the EU," says Mr de Bruijn, and continues, "ECHA does not have the underlying information on industry's substitution strategies or the reasons behind them. Overall, we see that the number of applications at the moment is lower than what the European Commission originally estimated when the impact of REACH was analysed."
ECHA's message to companies considering applying for authorisation is to consider its importance from a business perspective. "If you can substitute, you will spare the costs of the process. If you cannot, you will be able to present a good case to get the permission," Mr de Bruijn highlights.
The fee to ECHA for an application ranges from around 5 000 euros to up to a few hundred thousand euros – depending on the number of substances and uses applied for, the company size, and whether the application is submitted by only one company or jointly. The main cost will most probably not be the application itself but the preparatory work.
Restriction means obligation to substitute
Restriction of chemicals aims to limit the manufacture and import, placing on the market and/or on specific uses of a substance, which poses an unacceptable risk to human health or the environment.
If the restriction takes the form of a ban on all or some specific uses of a substance, substitution has to take place. REACH has taken over the restriction process from the previous legislation but introduced quite short deadlines for ECHA and the Commission to manage incoming proposals. As a result, the time needed for measures to be adopted and implemented has been substantially reduced.
As in the past, the use of substances that are classified as carcinogenic, mutagenic or toxic to reproduction (CMR) as such or in mixtures by consumers are restricted. New under REACH is a specific simplified procedure, which can be used to limit the use of CMR substances in articles. The Commission has proposed to use the new procedure for the first time for restricting the presence of polycyclic aromatic hydrocarbons (PAH) in articles.
Biocides and substitution
The new Biocidal Products Regulation also promotes substitution. In addition to the obligation to have the active substances approved and biocidal products authorised, the following criteria for substituting the most hazardous substances apply:
- The substance meets at least one of the exclusion criteria (CMR, endocrine disruptors; persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB)
- It is classified as a respiratory sensitiser
- Its toxicological reference values are significantly lower than those of the majority of approved active substances for the same product-type and use
- It meets two of the criteria to be considered as PBT
- It causes concerns for the environment even with very restrictive risk management measures
- It contains a significant proportion of non-active isomers or impurities.
If any of these criteria are met, the substance may be considered as a candidate for substitution. Candidates for substitution are identified during the approval of active substances and further reflected at the product authorisation stage, where the candidates for substitution trigger a comparative assessment of biocidal products.
ECHA to improve information online
While REACH, CLP and the BPR promote substitution by their very design, ECHA's role is to broadly promote substitution in all areas of the regulations and give strong incentives for industry to find and use safer alternatives.
To that end, ECHA is working on finding ways to more explicitly explain about the importance of substitution in the context of the REACH, CLP and the Biocidal Products Regulation. "We will further develop our website to guide users to the relevant explanations on how the substitution mechanisms are foreseen to work. We will also continue our dialogue with the accredited stakeholders on how to further promote substitution," Jack de Bruijn concludes.
Ongoing international work on substitution
The Organisation for Economic Co-operation and Development (OECD) established an adhoc group on the substitution of harmful chemicals in June 2012.
ECHA is co-chairing this group with the US Environmental Protection Agency. The group consists of representatives from governments, industry, academia, NGOs and trade unions.
Currently, the group is working on an inventory of the available tools and methods which can be used to characterise and compare hazards and exposures/risks.
The objective is to develop a toolbox that provides guidance on how to use priority tools and identify best practice. ECHA will contribute to this group to improve the knowledge on the costs of different substitution options. The first outcomes are planned to be ready in summer 2015.
Interview by Hanna-Kaisa Torkkeli
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Biocidal Products Committee:
30 November-4 December (tentative)
Committee for Risk Assessment:
6-8 October (RAC-52B);
30 November-4 December (tentative);
7-11 December (tentative)
Committee for Socio-Economic
30 November-4 December (tentative);
7-11 December (tentative)
Member State Committee:
7-11 December (tentative)
Management Board meeting: