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Facts and figures

In 2013 the EU-28 produced 30.7 million tonnes of the most toxic chemicals (carcinogenic, mutagenic, and reprotoxic chemicals).

  • (Eurostat: Energy, transport, and environment indicators 2015)
  • 4575 export notifications of banned or severely restricted chemicals and those subject to prior informed consent were made in 2014.

As of September 2015 51920 registration dossiers had been submitted to ECHA with information on 13441 unique substances.

About 25 per cent of registrations were made by companies in Germany and 12 per cent by UK companies.

In mid-2015 there were 163 ‘substances of very high concern’ on the so-called candidate list which means, inter alia, that consumers can request information about their presence in products.



The EU has a rather long tradition of regulating chemical substances. The first pieces of legislation in this field, adopted in the 1960s, were part of a programme for the elimination of technical barriers to trade. That was the case, inter alia, with Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.1 Gradually, however, environmental and health considerations came to play a more prominent role in chemicals regulation. An important step was the adoption, in 1976, of Directive 76/769/EEC on restrictions on the marketing and use of certain dangerous substances and preparations.2 It enabled the imposition of restrictions on the use of chemical substances and aimed to protect the public and also contribute to the protection of the environment.3 The extent to which this

i [1967] OJ 196/1. 2 [1976] OJ L 262/201.

3 Through the years a number of other legal acts banning or restricting the use of chemicals in specific products were also adopted. See, inter alia, Directive 75/716/EEC on the approximation of the

EU Environmental Law and Policy. David Langlet and Said Mahmoudi. © David Langlet and Said Mahmoudi 2016. Published 2016 by Oxford University Press.

Directive was harmonising was for a long time a matter of contention.4 However, in 2005 the Court of Justice made it clear that Member States were not allowed to subject the placing on the market of substances regulated by the Directive to conditions other than those laid down in the Directive.5

In 1979 Directive 67/548/EEC was amended so that protection of the environment became a primary aim and the placing on the market of chemical substances was made subject to a requirement to test new substances for dangerous properties.6 A still relevant distinction between ‘existing’ and ‘new’ chemical substances was thereby introduced. In order to place new substances on the market in quantities above a certain threshold after 18 September 1981, that is, the day when the amendments came into force, the manufacturer or importer had to submit to the competent authority a notification including, inter alia, information necessary for evaluating the foreseeable risks which the substance may entail for humans and the environment, including the results of certain studies specified in the Directive. The larger the volume to be marketed, the more information had to be provided and the more tests were required to be carried out.

No corresponding requirement for notification or risk assessment was introduced for all the ‘existing substances’. Those could continue to be placed on the market without testing as long as they had been included on a list of substances marketed between 1971 and 18 September 1981.7 In addition to the obvious implications for the protection of the environment and human health, this also created an unintended incentive for industry actors to keep producing ‘existing’ chemical substances, rather than innovating and developing new and better ones, which would require costly tests.8

In the 1990s a programme was set up under which 141 ‘existing chemicals’ were selected to undergo risk assessment and risk reduction measures.9 The risk assessments were carried out by the Member States, coordinated by the Commission, and based on data provided by manufacturers and importers. However, the programme was costly and slow to yield results. It was concluded that a new approach, more in tune with the polluter-pays principle, was needed and the Commission was tasked with developing a mechanism for dealing with the lack of knowledge concerning laws of the Member States relating to the sulphur content of certain liquid fuels [1975] OJ L 307/22; Directive 98/70/EC of the European Parliament and of the Council relating to the quality of petrol and diesel fuels ... [1998] OJ L 350/58; and Directive 94/62/EC on packaging and packaging waste [1994] OJ L 365/10.

  • 4 L Kramer, ‘Kemikalier och miljon: historien om den Europeiska gemenskapens kemikalielagstift- ning’ in E Ebbesson and D Langlet (eds) Koll pa kemikalier?: rattsliga forandringar, mojligheter och begransningar (Iustus, 2010) 43.
  • 5 Joined Cases C-281/03 and C-282/03 Cindu Chemicals and Others ECLI:EU:C:2005:549.
  • 6 [1979] OJ L 259/10.
  • 7 The European Inventory of Existing Commercial Substances (EINECS) originally listed all substances that were reported to be on the market between 1971 and 18 September 1981.
  • 8 J Scott ‘REACH: Combining Harmonization and Dynamism in the Regulation of Chemicals’ in J Scott (ed) Environmental Protection: European Law and Governance (Oxford University Press, 2009) 57.
  • 9 Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances [1993] OJ L 84/1.

‘existing chemicals’ according to which manufacturers, importers, and so-called downstream users should evaluate the risks.[1] [2] [3] [4] This led, after extensive consultations and heated debates, to the adoption, in 2007, of Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, (REACH) and establishing a European Chemicals Agency (ECHA).n

  • [1] Kramer ‘Kemikalier och miljon (n 4) 49; H Foth and AW Hayes, ‘Background of REACH inEU Regulations on Evaluation of Chemicals’ 2008 (27) Human & Experimental Toxicology 443—61.
  • [2] [2006] OJ L 396/1.
  • [3] According to the (non-binding) Guidance on requirements for substances in articles, version 2(European Chemicals Agency, April 2011), a printer cartridge is a combination of an article (functioning as a container) and a substance/mixture, a crayon is a mixture, and a battery is an article (with anintegral substance/mixture).
  • [4] 13 A ‘downstream user’ is any natural or legal person established within the EU, other than themanufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course ofhis industrial or professional activities. Distributors and consumers are not downstream users. Art 3.
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