Annexes to COM(2019)264 - Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2019)264 - Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps ...
document COM(2019)264 EN
date June 25, 2019
Annex 4 of the Commission's Staff Working Document on the Fitness Check of the most relevant chemicals legislation (excluding REACH) as well as related aspect of legislation applied to downstream industries.

(4)

COM(2012) 746 final

(5)

Except its Annex XIII laying out identification criteria for persistent, bioaccumulative, toxic and very persistent and very bioaccumulative substances. Findings of the second REACH evaluation are presentend in the ‘Commission General Report on the operation of REACH and review of certain elements’ (COM(2018) 116 final) and its accompanying Staff Working Documents (SWD(2018) 58 final).

(6)

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

(7)

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products

(8)

Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives

(9)

The pharmaceuticals, veterinary and food additives legislation was excluded from the scope of this Fitness Check because their hazard and risk assessment is based on different considerations (i.e. an assessment of the risk trade-offs between the health benefits of the medical product versus potential undesired side-effects). For example, under the Medicinal Products for Human Use Directive (2001/83/EC) the primary objective is to safeguard public health i.e. treat or prevent disease in human beings, restor, correct or modify physiological functions or make a medical diagnosis.

(10)

See Annex 3 of the accompanying Commission's Staff Working Document.

(11)

See Annex 2 of the accompanying Commission's Staff Working Document

(12)

Communication on options to address the interface between chemical, product and waste legislation (COM(2018) 32 final); Communication on the operation of REACH and review of certain elements (COM(2018) 116 final); ‘Towards a comprehensive European Union framework on endocrine disruptors’ (COM(2018) 734 final); ‘European Union Strategic approach to Pharmaceuticals in the Environment’ (COM(2019) 128 final)

(13)

REFIT Evaluation of the EU legislation on plant protection products and pesticides residues; Fitness Check of Reporting and Monitoring of EU Environment Policy; Evaluation of Regulation (EC) No 648/2004 (Detergents Regulation); the General Food Law Fitness Check; REFIT evaluation of the European Union occupational safety and health Directives. Please refer to Annex 4 Table 3 to see how different sources of information were used for the purposes of this Fitness Check.

(14)

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances

(15)

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

(16)

For example, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the Basel, Minamata, Rotterdam, and Stockholm Conventions as well as the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR)

(17)

In particular SDGs 3.9, 6.3, 12.4

(18)

COM(2015) 614 final

(19)

COM(2017) 479 final

(20)

Study on the cumulative health and environmental benefits of chemicals legislation p. 324

(21)

Special Eurobarometer 456

(22)

In spite of being out of the scope of this Fitness Check, this figure includes the EU contribution to ECHA for the operation of REACH Regulation as well as that for other pieces of legislation that EFSA is in charge of and which are not covered by this Fitness Check.

(23)

Funding came from the 7th as well as the 8th EU Framework Programme for Research and Development, with an annual avarege of EUR 35 million.

(24)

This figure includes the REACH Regulation that is not covered by this Fitness Check.

(25)

See for example European Human Biomonitoring Initiative (HBM4EU). The EU contribution amounts to around EUR 50 million. https://cordis.europa.eu/project/rcn/207219_en.html  

(26)

During the 2014-2016 period LIFE contribution to several projects in chemicals area amounted around EUR 5 million. See for example the following projects: FLAREX , VERMEER , MATHER , COMBASE , CHEREE , EXTRUCLEAN  

(27)

A project aiming at facilitating contacts between solutions providers and SMEs interested in substituting chemical substances of potential concern. The second phase of the project was launched in 2019.

(28)

  http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

(29)

The Scientific Committee on Consumer Safety (SCCS) , the Scientific Committee on Health, Environment and Emerging Risks (SCHEER) and, previously, the Scientific Committee on Occupational Exposure Limits (SCOEL), whose competences in terms occupational exposure to hazardous chemicals have been transferred since 2019 to the Risk Assessment Committee (RAC) of ECHA.

(30)

The CLP Regulation requires industry to ‘self-classify’ all substances placed on the market irrespective of tonnage. For hazards of highest concern (carcinogenicity, mutagenicity, reproductive toxicity (CMRs) and respiratory sensitisers) and for other substances on a case-by-case basis, classification and labelling should be harmonised throughout the EU in which case the Member States need to agree on the classification of a substance.

(31)

With regard in particular to online sales, the Commission has recently taken several initiatives involving market surveillance authorities (through the organisation since 2017 of yearly “e-enforcement academies” for improving online surveillance), consumers (with information campaigns on safe online shopping) and online economic operators (involving them in active fulfilment of their obligation thanks to the signature of the ‘ Product Safety Pledge ’ with key online sells platforms).

(32)

The ‘bridging principle method’ is a method applied when a mixture has not been tested to determine its hazardous properties, but there is sufficient data on similar tested mixtures and individual hazardous ingredients to adequately characterise the hazards of the mixture. In the case of detergents for example this method allows to avoid over-classification which may result from applying the calculation method usually preferred by smaller companies due to cost considerations. The lack of clarity with respect to how to apply the bridging principles hampers the effectiveness of the method and also leads to discrepancies in the interpretation and acceptance of the classification by Member States.

(33)

COM/2018/0179 final - 2018/088 (COD)

(34)

When considering the appropriate risk management for chemicals, a substance can be assessed in an isolated context (substance-specific; risk assessments completed on given substances under given settings) or as part of a substance group, i.e. chemicals with similar properties.

(35)

Special Eurobarometer 468

(36)

COM(2018) 734 final

(37)

  http://europa.eu/rapid/press-release_IP-11-664_en.htm ; Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials; applicable as of 6 September 2018

(38)

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes amongst other promotes the development, validation and implementation of alternative (non-animal) test methods.

(39)

COM/2012/0252 final

(40)

  https://www.efsa.europa.eu/en/press/news/130712 ; https://www.efsa.europa.eu/en/press/news/180626

(41)

  https://www.efsa.europa.eu/en/consultations/call/161024a  

(42)

COM(2019) 190 final

(43)

The intra-EU sales of chemicals increased from EUR 219 billion in 2006 to EUR 280 billion in 2016 (+28%). Domestic sales (sales in the home country) dropped from EUR 184 billion in 2006 to EUR 81 billion in 2016 (-56%). Extra-EU exports increased from EUR 102 billion in 2006 to EUR 146.2 billion in 2016 (+43%). Source: CEFIC Facts and Figures Report, 2017

(44)

Ibidem

(45)

COM/2017/0479 final

(46)

Reflection Paper ‘Towards a Sustainable Europe by 2030’ 30 January 2019

(47)

The United Nations Strategic Approach to Chemicals Management (SAICM); http://www.saicm.org

(48)

In line with the Commission communication 'The Goods Package: Reinforcing trust in the single market' (COM(2017/0787 final)

(49)

  http://ec.europa.eu/eurostat/statistics-explained/index.php/Chemicals_production_and_consumption_statistics

(50)

COM(2019) 190 final

(51)

Green chemistry is the utilisation of a set of principles that reduces or eliminates the use or generation of hazardous substances in the design, manufacture and application of chemical products. Definition by Anastas and Warner (1998).