Document 3NvgpwmzpaBYjve5aXbYmyz8O

BBve remeron EEB Envuirroopnamehniol Gh wecf Q HEAL Se ENVIRONMENT Bo cnr @ CProuoctevhoras wedwile chemsec O sr Qeuno Hogar Prt : (SdPiC) ClientEarth J 2 - wecf nrations Ds al 5 KAEVS EEELieto "a |CANTINE SANS S 4 rTopEEsam hAes pH WY BH rLmSs To: Executive Vice President Timmermans and Commissioners Breton, Sinkevicius, Kyriakides CC: Heads of Cabinets Samson, Moutarlier, Satnas, Rossides Re: Need to update the REACH information requirements Brussels, 27 February 2023 Joint NGO letter Dear Executive Vice President, Dear Commissioners We, the undersigned NGOs, warmly welcome your initiative to reform the EU flagship regulations REACH and CLP as part of the commitments made under the EU Chemicals Strategy for Sustainability (CSS). When it comes to the revision of the chemicals legislation the priority is to ensure a higher level of protection and minimise the rampant exposure of people and the environment to harmful chemicals. The reforms of the REACH and CLP regulatory systems are a crucial opportunity to address the current, undeniable data gaps1 and the need to speed up regulatory action on harmful chemicals2 . With this letter, we would like to express our serious concerns about these data gaps, which hamper an effective identification and risk management of the chemicals of most concern such as chemicals causing cancer, infertility, or disruption of our hormonal systems. In the absence of such data, regulatory decisions are not taken, and potentially harmful chemicals unnecessarily remain on the market, exposing billions of people and the environment for years to come. Therefore, the undersigned NGOs call on the EU authorities to: 1. Update the REACH information requirements to ensure the necessary information is available to protect people and the environment in line with the commitments of the CSS. The current information requirements under REACH are not sufficient for the identification of serious, long-term hazards for human health and wildlife. An update of the information requirements under REACH is urgently needed to enable an effective identification of all carcinogenic, reprotoxic and endocrine disrupting chemicals. While we support and share the efforts to reduce and limit tests on laboratory animals to the minimum, unfortunately for the moment, regulatory accepted new approach methods (NAMs) are not available to fully replace animal tests for the regulatory identification of the most serious hazards such as carcinogenicity and endocrine disrupting properties. Therefore, these are still needed when prioritising protection of citizens and wildlife. 2. Work towards a gradual transition to hazard identification based on NAMs in the future, as a foundation for the regulatory control of harmful chemicals As more reliable and regulatory accepted NAMs become available, a gradual transition towards NAM-based hazard identification can be made possible in the future. However, currently a full replacement of animal tests by NAMs is not yet possible given the too limited development of regulatory accepted NAMs covering all relevant hazards. 1 The unknown territory of chemical risks -- European Environment Agency 2 The Need For Speed - Why it takes the EU a decade to control harmful chemicals and how to secure more rapid protection - European Environmental Bureau European Environmental Bureau Rue des Deux glises 14-16, 1000 Brussels, Belgium +32 228 91090 eeb@eeb.org www.eeb.org International non-profit association Association internationale sans but lucratif (AISBL) EC register for interest representatives: ID number: 06798511314-27 BCE ID number: 0415.814.848 RPM Tribunal de l'entreprise francophone de Bruxelles 2 Therefore, we call for the introduction of legal provisions in the regulatory framework that allow the use of NAMs, when they are considered acceptable by regulatory authorities. In this way, they can effectively be used to serve the identification and regulatory control of the most hazardous chemicals. This will improve the level of protection, while gradually replacing animal testing. 3. Implement the precautionary approach3 to increase health and environment protection and reduce animal testing The precautionary approach is the most cost-efficient way to enhance protection of health and the environment, while reducing the need for animal testing. In the event that hazardous properties are identified for a substance, based on evidence from structurally related chemicals, NAMs, academic data and other existing information, this evidence should directly lead to a precautionary decision by authorities. Additional animal tests should not be required to prove the evident harm and there is no need to put people and wildlife at further risk. Ensuring better use of existing data for hazard identification and taking precautionary action to phase-out the most harmful chemicals from consumer products, will decrease the burden of evidence, while effectively reducing the need for animal tests. We have attached a position paper that elaborates on these proposals in more detail. We urge you to take action on these proposals to protect human health and the environment from hazardous chemicals and we would greatly appreciate the opportunity to further discuss our concerns and proposals in a meeting with you. Sincerely, , European Environmental Bureau (EEB) , CHEM Trust , Health and Environment Alliance (HEAL) , ChemSec Ecologistas en Accin, Spain , WECF France, Magyar Termszetvdk Szvetsge - Friends of the Earth Hungary ISDE (International society of Doctors for Environment Italy) 3 As stated in this EC communication. "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capability. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation European Environmental Bureau Rue des Deux glises 14-16, 1000 Brussels, Belgium +32 228 91090 eeb@eeb.org www.eeb.org International non-profit association Association internationale sans but lucratif (AISBL) EC register for interest representatives: ID number: 06798511314-27 BCE ID number: 0415.814.848 RPM Tribunal de l'entreprise francophone de Bruxelles 3 ZERO - Association for the Sustainability of the Earth System ClientEarth Brussels Office. WECF International She/her Woman Engage for a Common Future Hogar sin Txicos y Pte. Fodesam Bund fr Umwelt und Naturschutz Deutschland e.V. (BUND) Friends of the Earth Germany Gnrations Futures, France Tegengif, The Netherlands ECOCITY, Greece Plastic Change Cantine sans plastique France EDC-Free Europe rztInnen fr eine gesunde Umwelt (Doctors for the Environment Austria) Bond Beter Leefmilieu Corporate Europe Observatory (CEO) European Environmental Bureau Rue des Deux glises 14-16, 1000 Brussels, Belgium +32 228 91090 eeb@eeb.org www.eeb.org International non-profit association Association internationale sans but lucratif (AISBL) EC register for interest representatives: ID number: 06798511314-27 BCE ID number: 0415.814.848 RPM Tribunal de l'entreprise francophone de Bruxelles 4 Position paper Recommendations for working towards human health and environmental protection, while gradually replacing animal testing Context The REACH and CLP regulations are complementary to each other and aim to improve the protection of citizens and the environment against the threats from hazardous chemicals. Revision of both regulations is required to achieve the goals of the CSS. The foreseen revision of the CLP would be a major step forward with the inclusion of the new hazard classes for endocrine disrupting chemicals and persistent chemicals that either bioaccumulate in organisms or are mobile in water and pollute our drinking water. However, revision of the REACH Annexes is also needed to ensure that the information to identify these serious hazard properties becomes available, to enable companies to fulfil their obligations regarding safe use, and authorities to identify the substances of most concern such as chemicals causing cancer, infertility, or disruption of our hormonal systems. This information can then be used for increased risk management under REACH, as well as for other sectoral legislation. We call on the EU authorities to: 1. Update the standard registration requirements under REACH to enable an effective identification and regulation of hazardous chemicals in line with the commitments of the CSS 2. Work towards a gradual transition to hazard identification based on NAMs in the future, as a foundation for the regulatory control of harmful chemicals 3. Implement the precautionary approach4 to increase health and environment protection and reduce animal testing In this position paper, the NGO recommendations for improving protection of health and the environment, while gradually replacing animal testing are further elaborated. 1. Standard information requirements under REACH should allow for effective identification and regulation of hazardous chemicals as committed in the CSS The standard information requirements under REACH should allow for a swift identification of the hazardous properties of all harmful chemicals. However, the current information requirements under REACH are not sufficient for the identification of serious, long-term hazards. For example, they do not enable the identification of all carcinogens or chemicals that affect our hormonal systems. The European Environment Agency (EEA) reported in their 2020 outlook5 on the European environment about the unknown territory of chemical risks in Europe. Over 22.000 chemicals were registered under REACH and placed on the EU market. Only 500 of these chemicals were well characterised with respect to their hazards and exposure. 4As stated in this EC communication. "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capability. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation". 5 The European environment - state and outlook 2020 - European Environment Agency European Environmental Bureau Rue des Deux glises 14-16, 1000 Brussels, Belgium +32 228 91090 eeb@eeb.org www.eeb.org International non-profit association Association internationale sans but lucratif (AISBL) EC register for interest representatives: ID number: 06798511314-27 BCE ID number: 0415.814.848 RPM Tribunal de l'entreprise francophone de Bruxelles 5 ) 2EEB mr -- Eoo e i LL chemicals causing cancer, infertility, or disruption of our RR S T Es LIn E niaTg `duencniescieosnssarailryerenmotaintaoknentheanmdarkpeott,enetxipalolsyinhgabrmfiulloclfhepomeiocnapllsse. requirements in the REACH Annexes is urgently needed, to a L D --------T -- eT e TL----L_"n" adverse effects in intact organisms and effects in multiple generations. For example, NAMs do not enable the po `hazards, animal tests will stil play a role whengiving priority to the TI--E--S protectionofbillionsofcitizens, livestock. pets and allows earlier action based on different kindsofevidence (see point 3). E i E New assessment methods, new approach methods, or non-animal methods (NAMs) arewidely used under REACH by a R R I sa ye ran ri%ms property and NAMs are barely accepted by authorities to identify and regulate harmful chemicals. This is because the F = ETE soEE I -- EEE co . ) EeEunroEonpemBaenntal Brea Finuttruinrseicdesvubesltoapnmceentpsroipneritnitesr.oImncertehaosdesd,aicnc-eipltcaonmceetohfodNs,AaMndfoormtihcesivdienltcifoinctartiibountaentdoriemgpurloatvoerdypcroendtircotlioofn ohfaromtfhuelr cihnetrmoidcuacltsiowniolfcloengtarlipbruotveistiooanshiingthheerrleegvuellaotforpyroftreacmteiwonoraknhdaatcaclelloewrattheeruesgueloaftNorAy Macttihona.taTrheecroenfosried,erweedcaacllcefpotrabtlhee biyrmegpulraototvrhyeialunetvhgo!roiftipersotteoctsieornv,ewhtihekgirdaendtuiaflilcaytrioenduacnidngreagnuilmaatloreysctionngt.rAolgrofadtuhealmotrsatnshiatzioanrdtoouswacrhdesicaaNlAsM,.tbhearseebdy hbaezcaormdeiadveanitliafbilcea.tion can be made possible in the future as more reliable and regulatory accepted NAMs. Pirdoemntoitfiincagttihoneuasnedorfesgtrriocutpioanss.seTshsmceunrtrsenitsanpeperdoeadchasoaf rbeagsuilsaftoirnrgecghuelmiactaolrsyaoncet-iboyn-ssonuechtaaksecslaaslsoinfgictamtieona,nSdVhHaCs resulted inregretablesubstitution,asseenfo exampleith halogenatedflameretardants, phthalates,bisphenols and aPpEApSr.oaTchheerse,foursei,ngaurtehaodr-iatcireossssthoousltdrucsttuorpallryegruellaattiendgchcehmemiiccaall,sinonoer-dbery-oonespaeendd-umpovreegutloatwoarrydsacttihoen uosnehaofzagrrdoouups chemicals, whi reducing anima testing, 3. Implement the precautionary approach to increase health and environment protection and reduce anima testing hReagzualradtoorussschhoeumlidcawlosr,kwtiotwharthdes ariemdu1c0insgpetehdeubpurtdheenphoafpsre-ooouftfoofrtahuethmoorsittiheasztaordioduensticfhye,micclaaslssiftyo,tahnedberneegfuiltatoef peoples health an the environment as committed intheCS5and, a th same time,replacing animal esting. p`ofrNeAcMaSu)ttio oidneanuirsfeyyosfuablsltaavnacieasblheazeavriddoeuncsepr(ocpleurdtiiensgcionuflodrmpaltaiyoannfesrsoemntstiraulcrtoulrealilnyarcehliaetveidncghtehmeisceaglo,alasc.adfeemviicdednactea ninedeidca0tespuptotpeenotipalleahanrdmfwuil fpreopaetrtfiuersthoefr issku.bsWteanacdev,otchaetreefiosrntohenreeed dtousaccorftifaiincieomaadnlditteosntailngaan5immaulcshansdptohsesrieblisenboy ensuring a better use of existing information. Therefore, we promote the use of al avaible data for hazard Siedcetntoirfsi.cAatuitohnoraintdiersegsuhloautlodrybaectailolno,weindcltuoduisnegaalclaadveamiiacbldeaetv,iadnendcperfoormtohtereid-euntsiefiacnadtisonhoafrhinagromfflullecxhiesmtiicngaldsataanadctraokses 2NpArMecawuetiroencaorymmaepnpdroaaccohmtpaorraitsikvmeasntuadgyeomneNnAtWw-ibtahsoeutd dhealzaayr.dTiodeinntcirfeiacasteitonheancdonefxipdeernicmeenintatlhedarteag-ublaatsoerdy huaszearodf identification of substancaes a stating point. The precautionary approach is the mst cost-fficent way t enhance: protectiofn health and the environment, whi reducing the need fr animal esting. Cohotshsneatrtceeodpcanbmihtsyr,EWceCheaeoepmrreeaatre,rveaneso.nredtrodtsorportevehersveodanmatge,,ctekpoecuatciornarcyaepparotachshlallbebiedslyecpsl absyoStfoersposcpndeg ee--s----O-- oo----14--16b10e00--BCrrs--,psS--npttn--onm5etnucrsnO 1ts00 GweerFe vmotae ry oe 437 ErbST 88 AotepenBt 7 Final note on animal testing - Looking at the source of the problem Animals are used in laboratory experiments for various purposes. According to the latest EU statistics9, the large majority of animals are used for research purposes, while only 1.5% of the animals were used for the purpose of REACH. This is a further decrease of the share of animals used under the REACH regulation since 2017 (see figure)10. 9 Summary Report on the statistics on the use of animals for scientific purposes in the Member States of the European Union and Norway in 2019 (Commission Staff Working Document 2022) 10 In 2017 the use of animals for scientific purposes was mainly reported for research (69 %), followed by regulatory use to satisfy legislative requirements (23 %) and routine production (5 %); whereas among the testing carried out for regulatory purposes, the majority involved medical products for humans (61 %), followed by veterinary medicinal products (15 %) and industrial chemicals (11 %) (EP resolution 2021/2784(RSP)). European Environmental Bureau Rue des Deux glises 14-16, 1000 Brussels, Belgium +32 228 91090 eeb@eeb.org www.eeb.org International non-profit association Association internationale sans but lucratif (AISBL) EC register for interest representatives: ID number: 06798511314-27 BCE ID number: 0415.814.848 RPM Tribunal de l'entreprise francophone de Bruxelles 8