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Hazard v. Risk in EU Chemicals Regulation

Published online by Cambridge University Press:  20 January 2017

Kristina Nordlander ,
Carl-Michael Simon  and
Hazel Pearson
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Abstract

Hazard is the potential of something to cause harm; risk is the likelihood of harm occurring. Chemicals regulation is largely focused on minimising risks associated with chemicals — and rightly so. However, in the EU the hazard classification of individual chemicals can impact significantly the regulation of products containing those chemicals, regardless of the actual risks that the products may pose to human health or the environment. This can lead to undesirable consequences, such as restrictions on the use of safe products, substitution towards less safe products, and disincentives to innovate. Such hazard-based regulation tends to be at odds with World Trade Organization rules and has raised significant concern with EU trading partners. This journal is an ideal forum for discussing how the EU can move towards a better and more coordinated legal framework for the regulation of chemicals.

Type
Articles
Information
European Journal of Risk Regulation , Volume 1 , Issue 3 , September 2010 , pp. 239 - 250
Copyright
Copyright © Cambridge University Press 2010

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References

1 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, OJ 1967 L 196/1, as amended.

2 Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, OJ 1999 L 200/1, as amended.

3 See <http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html>.

4 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, etc., OJ 2008 L 353/1.

5 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), etc., OJ 2006 L 396/1, as amended.

6 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ 2009 L 309/1.

7 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, OJ 2009 L 342/59.

8 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, OJ 2001 L 311/67.

9 For simplicity's sake, we have combined in one step what is sometimes described in two: (1) identifying the adverse effect(s) associated with chemical and (2) established the dose-response relationship between the chemical and the adverse effect.

10 There are many challenging technical issues that can arise in the course of understanding the hazards posed by a particular chemical, ranging from the accuracy and validity of laboratory tests, extrapolating from animal tests valid conclusions about adverse effects to humans (not to mention the highly-charged issue of whether animal tests should be used at all), linear v. non-linear dose-response relationships, to understanding the chemical's ‘mode of action’ on human and environmental receptors (i.e. how the chemical actually causes the adverse effect). Of particular interest are the assumptions made or models used when there is insufficient data regarding the toxicity and properties of the ‘target’ chemical, and information or conclusions are ‘read across’ from other chemicals on which there is more data.

11 See REACH, Article 1(3) and recitals (9) and (69).

12 “The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty.” Communication from the Commission on the precautionary principle, COM(2000) 1, section 6.1, p. 16.

13 Under EU chemicals legislation, ‘substance’ generally means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. See CLP Regulation, Article 2(7) and REACH, Article 3(1).

14 Under EU chemicals legislation, ‘mixture’ (or ‘preparation’ as it was known prior to the CLP Regulation) generally means a mixture or solution composed of two or more substances. See CLP Regulation, Article 2(8) and REACH, Article 3(2).

15 DSD, Annex VI, para. 1.1.

16 DSD, Annex VI, para. 1.1.

17 European Commission, “Summary Record from the Session on Classification of Boric Acid and Borates of the Meeting of the Technical Committee on Classification and Labelling of Dangerous Substances and Preparatory Meeting for the Technical Progress Committee of Directive 67/548/EEC, Arona, September 8, 2005”, dated 20 February 2006 (ECBI/43/05 Rev. 1), p. 18.

18 See, for instance, C-14/10 Nickel Institute and C-15/10 Etimine (both pending).

19 Emphasis added. See also CLP Regulation, Articles 5(1), 6(1) and 8(6) and DSD, Article 4.

20 European Chemicals Agency, “Introductory Guidance on the CLP Regulation”, ECHA-09-G-01-EN, 25 August 2009, at pp. 7–8.

21 Under the DSD, the three categories of CMRs are: category 1 – proven CMR based on human data; category 2 – CMR based on animal data; and category 3 – suspected CMR. Under the CLP Regulation, there are also three analogous CMR categories, but they are known as categories 1A, 1B and 2.

22 For instance, under Article 3 of the CLP Regulation, “a substance […] fulfilling criteria related to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.” The CLP Regulation includes the hazard classes found in the DSD, as well as certain other new ones that originate from the GHS.

23 Under the DSD/DPD, the standard phrases on the nature of special risks from substances were called R-phrases.

24 Under the DSD/DPD, the safety precaution phrases relating to the handling and use of dangerous substances were called S-phrases.

25 REACH, Annex I sets out the rules for preparing chemical safety reports and states that “The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks…” (para. 0.1).

26 NB. One of the purposes of REACH, and the registration obligations in particular, is to generate more information about chemical substances in order to facilitate their classification.

27 See REACH, Annex XVII, Entries 28–30.

28 ‘PBT’ means ‘persistent, bioaccumulative and toxic’, ‘vPvB’ means ‘very persistent and very bioaccumulative’. See REACH, Annex XIII for the criteria for their identification.

29 REACH, Article 59(2) and (3).

30 This was an argument that was made by the applicants in a recent request to the General Court for the suspension of a decision to add the chemical acrylamide to the REACH Candidate List. although the President of the General Court dismissed the Application citing that the applicant did not demonstrate that it would lose market share and have to close its production plant as a result of the listing. See Order of the President of the General Court of 26 March 2010 in Case T-1/10 R, SNF SAS v. European Chemicals Agency (ECHA), (not yet published) para. 51.

31 Plant Protection Regulation, Annex II, para. 3.6.

32 Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ 1976 L 262/169.

33 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ 2002 L 31/1.

34 Cosmetics Regulation, Article 15(2).

35 Cosmetics Regulation, Article 15(1).

36 In the case of carcinogens, it is also possible that this regulation is based on an assumption of a linear dose-response relationship, whereby there is no dose at which there is no risk of cancer from a carcinogen. However, there is considerable scientific dispute over the validity of a linear dose-response assumption for carcinogens, with many scientists arguing that, at least for some chemicals, there are threshold concentrations that must be exceeded before there is any risk of cancer.

37 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, OJ 2001 L 311/67.

38 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, OJ 2002 L 11/4.

39 See, for example, Dr. James Gilmour, “Risk not hazard for good pesticides regulation”, 16 October 2008 available on the Internet at <http://euractiv.blogactiv.eu/2008/10/16/risk-not-hazard-forgood-regulation/>.

40 See DSD, Article 1(2)(d), DPD, Article 1(5)(d) and CLP Regulation, Article 1(5)(e).

41 See <http://www.chemsec.org/list/>. See also Order of the President of the General Court of 26 March 2010 in Case T.1/10 R, SNF SAS v. European Chemicals Agency (ECHA), (not yet published).

42 See, for example, the comments of Canada, Cuba, China, Ecuador, Colombia, Dominican Republic, Venezuela, Japan, Mauritius, Brazil, Indonesia, Philippines, Australia, Korea, Botswana, Zimbabwe, South Africa, Turkey, India, Chile, United States and Russia, as recorded in the minutes of the TBT Committee meeting of 5–6 November 2008, criticising the EC's proposed classification of borates and nickel compounds.

43 For example, the OECD has recently launched an online ‘toolkit’ for assessing and managing environmental risks of chemicals. The toolkit site describes the work flow of environmental risk assessment and management for chemicals, providing links to relevant OECD products that can be used at each step. The OECD toolkit is available on the Internet at <http://www.oecd.org/document/54/0,3343,en_2649_34373_44909430_1_1_1_1,00.html>.