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AmCham event 24 February The future of risk management in EU chemicals policy Kristin Schreiber, DG GROW MS have unanimously supported the ambition of the strategy - they are also very much behind the calls for strengthening the generic approach to risk management, the introduction of a mixture assessment factor and limiting the use of endocrine disruptors and persistent substances to essential uses. CSS - it is much more relevant how those elements will be implemented. This is currently being assessed in the impact assessments on the planned legislative revisions, including REACH and CLP. Extension of the generic or hazard-based approach to risk management - the essence of the precautionary principle as enshrined in the EU Treaty. Reasoning behind the generic approach to risk management - carcinogenic, mutagenic and reprotoxic substances are banned by default in cosmetics, toys, plant protection products and biocides, but also in REACH for any consumer uses as substances on their own or in mixtures. Thus, the question is not whether to apply the generic approach to risk management, but for what hazard classes and for which uses. Additional hazard classes - substances cause serious and mostly irreversible effects that EU citizens are very concerned about. Identifying risks for those substances - procedures must be simplified. Our plan is not a blanket ban for all substances in all concerned hazard classes - we will introduce generic restrictions in a step by step way, according to a work plan. The way to do this is currently being assessed in the impact assessment for the REACH revision. There will be exemptions for essential uses. Main challenge - make the procedures for granting such derogations clear and lean. Reform of authorisation and restriction procedures -> allow broader and generally applicable derogations, without the need for separate authorisations per applicant or groups of applicants. This should in particular help SMEs, which have difficulties to put together all the necessary information for authorisation applications. Important - define clear and simple procedures for assessing essentiality, in particular for clearly essential or clearly non-essential uses. For all other cases, there will still be a need for a detailed scientific and technical assessment. Invited stakeholders to participate in our public consultation on the REACH revision, which is open until 15 April. Workshops - on essential uses on 3 March and two more on REACH authorisation and restrictions, on 21 March and tentatively on 7 June. BfR (German Institute for Risk Assessment) GRA and Essential Use Concept (EUC) EUG concept is Integral artof the Generic Risk Management Approach GRAY" for consumer products + BMaonns"tmaosrhsuagrpomt"s ickh.aBruat ccoondeappanrsobdes"(1c.hnacrinwicihaclalsi)snndeansge"reosussepnrope1rt3ies0wi"b.e banned ARlEAnConHesCsoerntriaatleudseoscarsewchonsidperroecdhdeiscpeonnsasbmloe.rianhGoow(irhondprooa)kccahrsc3insdioegnaloISmEpAUcsons? ++ CPrOoMdulctsrmasytboe rnetmoovperdofoesmsbioenm!aurskee,toatvhenrDdagngrnouysmpryopeorttipesose okoconsumes. Examplesofconsumerproducts that could be afectd because they contain dangerous substances +eetsaotcsscr(r1osnduMcTwa,hNaos,nn.).. CWoo.psa)lts,Bsnakreirnoor u()earsiucsRnhoarracvtbe,rscdorhco)y_ogtdehse,,oav(drmc)hoedno)landadrpbiaenoss ard omproduc di. OY andcortvetonmat Conclusions The infin of ieGSS o improvethe efficienocyfEuropean chemical logislaton is strongly supported However, thegeneral equation of dangerouschemicalswith hazardous chemicisanlostbackedupby science. ATomtpbecetrtoomfaprrocpoonssalesquunednecrehse CSS need further discussion and mre thorough analysis, inpricuarwith Tehhomoicialsliimnittheodweovri.dencoef urgency to improve wha is already one of the most protective regulatory systems or mTohsatipmrmacatniscaoltsicmoenpsre.ssure and simultancousness of development also ara not helpful ornding tha bost and Discussion Question to KS How is the Commission planning to ensure the CSS is conducive to a competitive, innovative and resilient EU industry? Kristin Schreiber The challenge to policy makers is to make the regulatory framework as strong but also as lean and practical as possible and to work together with industry on ways to overcome barriers in that transition. Focus our resources where they are most needed (as said). Make sure that the tools will be clear and strong but also simple, so that we can achieve more with less resources in authorities and companies, and to make sure that those tools also work for SMEs. Make sure that the future regulatory framework will be conducive to innovation - called for ideas from stakeholders. We want innovation to take place in Europe. Work on transition pathways to the implementation of all three C's, climate neutrality, circular economy and chemicals safety. The work on the transition pathway for the Chemicals industry has been launched at the industry days on 7 February. We expect to present a first draft of the transition pathway at the 18 May High Level Roundtable. SME United Authorisation system has been especially difficult for SMEs. Good we are exploring alternatives. GRA and professional users - should they be treated as individual users eventually? A key issue - the short DDL. There are about 80 actions in the CSS to be implemented until 2024, looking into very important elements of chemicals legislation. This is a very short time. Limited resources for input. If the Commission expects quality input, more time would be needed to assess the proposals. Ex: SCIP system - it has been implemented quickly without much planning, we should not repeat this mistake with chemicals legislation. Essential uses: We are filtering cases that are political. On some cases, there is no need to get a scientific opinion. But, there are also cases where we'd like to have faster decisions in favour of essential uses, without going through the lengthy scientific assessment. SME United There is inconsistency between the political will and what we can resource and finance as MS/authorities. ECHA is getting additional work, but so are the enforcement authorities in MS. Some MS only have 2-3 chemicals experts. We need to raise the level of protection for consumers, professional and industrial users, and we are not going sufficiently into this. Good that the HLRT picked up on this topic. If we go into too rigid system, instead of reducing the work of authorities, it will be counter-productive. Risk option management analysis process is, therefore, important. We should not just talk about chemicals, we should talk about uses of chemicals. BfR are not against essential uses, he's only worried if this is turned into a negative goal - over-regulate all substances that are not deemed as essential. Comments & Questions from the Audience Covestro - The essential use concept can only be used for broad restrictions covering all uses. REACH Restrictions are not only "bans" and can be other options for risk management (e.g. training requirements), and also targeted Restrictions. What will be the future of targeted Restrictions for DG GROW? Moving to broad Restrictions only could be a de facto reversal of the burden of proof in drafting Restrictions from authorities to companies having to prove safe use/essentiality. Kreab: We are already witnessing the implementation of the generic risk assessment to restrict articles for hazard classes not mentioned in the CSS, as it is the case of the skin sensitisers restriction in textile and leather articles. An interesting element of this restriction is the dynamic link, which goes one steps further in the application of the generic risk assessment by proposing to automatically ban/restric substances that will be added to CLP in the future, even if they don't present a risk for consumers. How could the essential use concept be used in this regard, if we're talking about colouring/treatment of clothes and footwear? Shouldn't there be a possibility to request derogations for safe use? : While using hazard assessment as the basis of CSS is clearly a mistaken approach, as has been presented by and argued by the regulatory community in general, there is even a major bias when assessing the perceived hazards of substances on the basis of scientific studies published in the scientific literature. Scientific journals historically only accept publications with positive results of tox studies, hence the "body of evidence" available to assess the hazard of substances is a priori skewed. Has the Commission worked with the scientific community and major academic institutions and scientific journals to address this basic bias and launch a new strategy that journals also publish toxicological studies with negative outcome? ExxonMobil Europe: Almost any substance can be determined to be a CMR/ED depending on the dose, the type of study and increasingly the interpretation of the data - and not taking into account the robustness and quality of studies - this is a fundamental issue. Essential use should be left to the market - otherwise we will see many unintended consequences. Having a committee decide on essential use is ideology in action and spells the end of the market economy - which has brought so many benefits. This is in effect anti democratic i.e. we the regulators know better than the market economy and public on detailed uses of substances- and we see literally today where this thinking can take us. (German Steel Association) The presence of a harzardous substance in a product should not be the focus of restrictions. The real risc occouring shall be regarded. How the planned revisions of REACH and other regulations will implement this issue (focussing currently only on substances and not the expected emission/ release of the regarded substance) ? Professional users - it is important to distinguish between different types of generic users. However, we should also be aware that certain groups of professional users are not necessarily better trained. There will be a debate on this during the two workshops in March and June. There is a clear will in Europe to enhance protection. Recap from AmCham: Opportunity to simplify processes (Schreiber's message). Make better use of scientific advice and evidence. CSS will be implemented as it is - no point in challenging it, we need to work on the details - focusing on the "how". Much debate on the "safe use" concept.