COMMISSION REGULATION (EU) …/… 

of XXX 

amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament  and of the Council as regards formaldehyde and formaldehyde releasers 

(Text with EEA relevance) 

THE EUROPEAN COMMISSION, 

Having regard to the Treaty on the Functioning of the European Union, 

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the  Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and  Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending  Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission  Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission  Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1 , and in particular Article  68(1) thereof,

Whereas: 

(1) Formaldehyde is a highly reactive gas at ambient temperature and atmospheric  pressure conditions. It is classified in Part 3 of Annex VI to Regulation (EC) No  1272/2008 of the European Parliament and of the Council2 as carcinogen category 1B,  mutagen category 2, acute toxicant category 3, skin corrosive category 1B and skin  sensitiser category 1.  

(2) Formaldehyde is a high production volume chemical with a wide array of uses. It is  also produced endogenously in humans and animals, and it is an essential metabolic  intermediate in all cells. 98 % of the formaldehyde manufactured or imported in the  Union is used as a chemical intermediate in the production of formaldehyde-based  resins, thermoplastics and other chemicals, which are further used in a broad range of  applications. Formaldehyde-based resins are used in the production of a wide variety of articles, which, as a result, may release formaldehyde. The primary use of  formaldehyde-based resins is in the manufacturing of wood-based panels, where they  act as a bonding agent for wood particles. Such resins are also used in the production  of other wood-based products like furniture and flooring, and for wallpapers, foams,  parts for vehicles and aeroplanes, textile and leather products. 

(3) On 20 December 2017, pursuant to Article 69(1) of Regulation (EC) No 1907/2006  the Commission asked the European Chemicals Agency (‘the Agency’) to prepare a  dossier which conforms to the requirements of Annex XV to that Regulation(hereinafter ‘the Annex XV dossier’), in order to assess the risk to human health from  formaldehyde and formaldehyde releasing substances in mixtures and articles for  consumer uses. 

(4) On 11 March 2019, the Agency (to be known as ‘the Dossier Submitter’ in the context  of submission of a dossier) submitted the Annex XV dossier4 , which demonstrated that  the risk to human health from formaldehyde released from consumer articles in indoor  environments is not adequately controlled under all scenarios, and that action on a  Union-wide basis is necessary to address that risk.  

(5) The Dossier Submitter assessed the hazard of formaldehyde by considering the effects  of the substance on several endpoints, concluding that the risk from inhalation leading  to sensory irritation is the most sensitive effect in humans. The Annex XV dossier  assessed the risks from inhalation of formaldehyde associated to consumer exposure  against the World Health Organization (WHO) Guideline for Indoor Air Quality for  formaldehyde (30-minute average concentration based on sensory irritation in  humans)5 . The Guideline provides for a short-term value (0,1 mg/m³) with a view to  preventing detrimental effects on lung function, as well as long-term health effects,  including nasopharyngeal cancer. The Dossier Submitter used that value as the level  above which humans should not be exposed (derived no-effect level (‘DNEL’) and to  calculate the proposed emission limit of 0,124 mg/m³. 

(6) Based on available literature and the outcome of the exposure estimation, the Dossier  Submitter concluded that human health risks from formaldehyde release from mixtures  for consumer use are adequately controlled.  

(7) The Annex XV dossier therefore proposed to prohibit the placing on the market of formaldehyde and formaldehyde releasing substances in articles generating consumer  exposure where the formaldehyde releases lead to concentrations exceeding 0,124 mg/m³ in the air of a test chamber. Moreover, the Annex XV dossier specified  that formaldehyde in road vehicles and aircraft, where formaldehyde or formaldehyde releasing substances were intentionally added during their production, should not be  placed on the market if the formaldehyde measured in their interior exceeds a  concentration of 0,1 mg/m³ and where exposure of formaldehyde to consumers can  occur there. 

(8) The Dossier Submitter’s original proposal established EN 717-1 as the standard  method to measure in a test chamber the emissions for formaldehyde released from  wood based panels. To clarify that other suitable test methods can also be used and to  cover articles other than wood-based panels, the Dossier Submitter replaced the  reference to standard EN 717-1 in its proposal by a wider description of conditions and  methods. Ambient conditions may have an influence on formaldehyde emissions from  articles and therefore relevant testing parameters were also listed in the Annex XV  dossier.  

(9) On 13 March 2020, the Agency’s Committee for Risk Assessment (‘RAC’) adopted its  opinion. In its opinion, RAC considered the WHO guideline value not sufficiently  protective for the general population and concluded in particular that short-term  sensory irritation effects in humans cannot be used to predict long-term effects such as  cancer. RAC instead set a DNEL of 0,05 mg/m³ derived from data on chronic effects in animals for the inhalation route and concluded that a limit value of 0,05 mg/m³ for  formaldehyde released from articles and for formaldehyde in the interior of road  vehicles was needed to control the risk. 

(10) RAC concluded that the risk to passengers from formaldehyde in aircraft is adequately controlled. 

以上为部分截取，获取全文请联系info@murqa.com  

上海沐睿科技服务有限公司是国内专业从事汽车法规合规的第三方咨询公司，多年来，为上汽，长城，宇通，大通，爱驰，蔚来等OEM提供汽车环保法规合规服务，团队跟踪与研究全球的环保合规，期待为更多的企业提供服务。www.automds.cn      

免责声明：版权归原作者所有，如有侵权请联系删除；文章内容属作者个人观点，不代表本公司观点和立场。转载请注明来源；文章内容如有偏颇，敬请各位指正。