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Harmonising effect

In addition to being based on a Treaty provision relating to the internal market, REACH also contains, in Article 128, a so-called internal market clause. According to that the Member States may not ‘prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance’—on its own, in a mixture, or in an article—falling ‘within the scope’ of REACH, which complies with that Regulation and with any other EU acts adopted in implementation of REACH.

Except for the limited room for national exceptions allowed under what is now Article 114 TFEU, the Member States are prevented from applying any rules that differ from REACH within the scope of the Regulation. Exactly what should be deemed to fall within that scope is not always clear. With respect to substances that are subject to authorisation, there is hardly any room for national restrictions on use of a general nature. However, it must be assumed that use may be restricted in small areas due to specific circumstances since an authorisation on the EU level cannot possibly consider all local needs, such as water sources or the need to protect the breeding ground of a threatened, sensitive species. Any other interpretation would make impossible measures that are essential, inter alia, for protecting human health unless they are explicitly provided for by EU workplace and environmental legislation (since such measures are given priority in relation to REACH). REACH should also not limit the right to impose restrictions on chemicals due to safety concerns, for example the fact that a chemical is highly explosive, since the prevention of accidents or terrorist attacks involving chemicals is not among the aims of


With respect to substances that are subject to restrictions, the Court of Justice has made clear that REACH harmonises the requirements relating to the manufacture, placing on the market, or use.2[2] However, the same argument for allowing site-specific restrictions applies here as with respect to substances that need authorisation.

For the large number of substances that have only been registered, there has typically not been any real evaluation of the risks by ECHA or the Member State authorities. What should not be permissible with respect to these substances is to make their marketing or use conditional on the provision of information additional to that required for the registration.[3] [4] But it does not seem warranted to make them subject to equally far-reaching harmonisation as that which applies with respect to substances subject to authorisation or restrictions. Whether there is a need for EUwide action to manage the risks associated with these substances has typically not been assessed.

Article 128 also has a second paragraph, according to which nothing in REACH shall prevent Member States from maintaining or laying down national rules to protect workers, human health, and the environment applying in cases where REACH ‘does not harmonise the requirements on manufacture, placing on the market or use’. Literally interpreted, this seems to state the obvious: issues that are not harmonised by REACH are not harmonised by REACH. However, the second paragraph does serve to disprove the otherwise conceivable interpretation of the phrase ‘falling within the scope of [REACH]’ as implying a harmonising effect that goes beyond the actual provisions of the Regulation. It also signals more generally that the harmonising effect should not be extensively construed and that only those cases that are clearly covered by provisions in REACH are to be regarded as harmonised. In line with this, the Court of Justice has held that the EU legislature only intended to harmonise the requirements for the use of a substance ‘in certain cases’, such as when restrictions apply.31 That does not seem compatible with making registration—which is required for almost all chemicals—entail full harmonisation.

In this context it should be recalled that REACH, according to Article 2, applies without prejudice to EU workplace and environmental legislation. Measures taken in accordance with EU environment legislation therefore do not violate REACH even if they restrict the handling of chemicals in ways that are prima facie incompatible with the Regulation. However, this cannot extend to such more stringent protective measures as the Member States may take in accordance with Article 193 TFEU.32

Further provisions

The Member States are required to maintain a system of official controls and other activities as appropriate to the circumstances. They shall also lay down provisions on penalties applicable for infringement of the provisions of REACH and take all measures necessary to ensure that they are implemented (Arts 125 and 126).

REACH also contains provisions on, inter alia, fees and charges (Title IX), the structure of and tasks to be performed by ECHA (Title X), competent authorities (Title XIII), and reporting and access to information (Title XII).

  • [1] See, by analogy, Case C-288/08 Nordiska DentalECLI:EU:C:2009:718, para 31.
  • [2] Case C-358/11 Lapin luonnonsuojelupiiri ECLI:EU:C:2013:142, para 38.
  • [3] At the time of writing a case is pending before the Court of Justice in which a Swedish court hasasked the Court of Justice whether it is permissible to require an importer of a chemical product, inrespect of which there is an obligation to notify under REACH, to notify it in accordance with nationallegislation for registration in a national product register. That requirement does not, however, requirethe production of new information. Case C-472/14 Canadian Oil Company Sweden andRanten [2014]OJ C 448/15.
  • [4] Case C-358/11 Lapin luonnonsuojelupiiri (n 29) para 33.
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