Generic approach to risk management (GRA)
The Extension of the Generic Approach to Risk Management in the European Commission’s Chemicals Strategy for Sustainability
On 14 October 2020, the European Commission published its Chemicals Strategy for Sustainability (CSS), which is part of the European Union’s zero pollution ambitions outlined in the European Green Deal. The CSS is a major initiative which will redefine the EU chemical policy, prioritise intervention and substitution, and move sharply towards generic restrictions.
The CSS contains 56 actions, most of them legislative changes, including a targeted revision of REACH. The extension of the Generic Approach to Risk Management to professional uses will have significant impacts on users of adhesives and sealants.
FEICA aims to promote the development of a European platform for the information and training of professional users covering the risks arising from the most harmful chemicals. This initiative would be more proportionate than the generic ban of substances for professionals.
Please see the FEICA Position Paper: FEICA’s proposal to improve the protection of professional workers using the most harmful chemicals.
FEICA also developed a leaflet on the GRA and an example to illustrate the impact of a possible implementation of a generic restriction (ban) on consumer/professional use of silicon dioxide. The slide deck can be viewed here.
The European Commission would like to extend the scope of application of the Generic Approach to Risk Management (Art 68.2 of REACH). The scope would be extended from consumers to professional users, and from carcinogens, mutagens and reprotoxic chemicals (CMR) to other hazard classes (some under discussion), such as endocrine disruptors (ED), persistent, bioaccumulative and toxic (PBT) substances, very persistent and very bioaccumulative (vPvB) substances, persistent, mobile, toxic (PMT) substances, very persistent and very mobile (vPvM) substances, substances of specific target organ toxicity – single exposure (STOT SE) substances of specific target organ toxicity – repeated exposure (STOT RE) and respiratory sensitisers.
The generic approach to risk management, also called the hazard-based approach, targets chemicals for regulatory action based on intrinsic hazard properties only regardless of where and how the chemicals will be used and regardless of whether there is any actual risk present.
Under the generic approach to risk management, no risk assessment takes place, and, therefore, use conditions and risk management measures in place for ensuring safe use are not considered.
The European Chemicals Agency (ECHA) committees - the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) - and the Member States are not involved in managing risk.
This could result in professional users (such as workers in the construction sector or repair shops) not being allowed to work with adhesives and sealants which contain substances with hazardous properties.
FEICA considers the extension of the generic approach to risk management to professional uses inappropriate and disproportionate. The use of chemical products by professional workers differs considerably from that by consumers and should, therefore, not be subject to the same restrictions or prohibitions. In fact, professional users have more characteristics in common with industrial users than with consumers. Should the need for a specific regulatory risk management measure regarding professionals be identified, the current legal framework already provides an appropriate set of tools.
Professional workers perform tasks that are important for society and the circular economy, and they need chemical products to perform those tasks. The application of the generic approach would adversely affect the availability of substances and products. For example, certain reactive resins that are used in the construction sector might be restricted or even prohibited by the generic approach. Furthermore, many adhesives and sealants are enablers of the European Green Deal’s Circular Economy Action Plan. The extension of the generic approach to risk management could limit the use of these adhesives and sealants.
Professional workers, such as construction workers or workers in repair shops, would end up having to work with products available to consumers, the technical functionalities provided by the restricted chemicals being unavailable. The range of potentially affected uses is increasing enormously, and the extension to additional hazard classes exacerbates the problem.
FEICA members are committed to ensuring the highest level of protection for professionals and believe that there are ways to safeguard professional workers other than generic substance bans without a risk assessment having been performed.
FEICA members would like to propose the development of a European platform for the information and training of professional users covering the risks arising from the most harmful chemicals as identified by the Commission.
In addition, giving a more formal place to the Regulatory Management Option Analysis (RMOA) in REACH, making this mandatory before any regulatory measure is undertaken, would be a first significant step forward. A RMOA should guide the understanding of hazards and exposures and help assess whether the Occupational Safety and Health (OSH) route or the REACH route (i.e. authorization or restriction) should be selected. For instance, if OSH measures according to the hierarchy of control are not in place, and there is no binding Occupational Exposure Limit (OEL) or biological limit value (BLV), a REACH restriction and training obligations should be preferred. Eventually the application of a hazard-based generic use restriction could be the outcome of the RMOA.
The setting of binding OELs for professional uses at risk could be considered, too. In some cases, the setting of binding OELs could be even more effective than REACH restrictions.
We will keep our members and the industry updated on any developments, including through this channel.