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CJEU clarifies measurement of dangerous substances in products

The threshold for measuring whether a product contains 'substances of very high concern' (SVHC) applies to each article that is incorporated in a complex product rather than to the whole product, the CJEU has said23 Sep 2015

Under the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, which came into force in 2007, a product has to be notified as containing SVHCs if it passes a 0.1% threshold, and information has to be provided on what it contains.  However, there has been disagreement among regulators in EU countries as to whether this applies to individual articles or to the final product, the court said.

As the REACH regulation does not specifically address the situation of a complex product, "there is no need to draw a distinction between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner," said the CJEU, Europe's highest court.

Therefore, it said, "each of the articles, incorporated as a component of a complex product, is covered by the relevant duties to notify and provide information, when they contain an SVHC in a concentration above 0.1 % of their mass."

This means that if one article within a product contains more than 0.1% of one or more SVHCs, then the final product has to be labelled, even if the concentration of SVHC in the final product formulation is less than 0.1 % and falls under the threshold.

An article is defined by REACH as "an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition".

The case was raised by two French building trade bodies, the Fédération des entreprises du commerce et de la distribution (FCD) and the Fédération des magasins de bricolage et de l’aménagement de la maison (FMB).

The French Conseil d'Etat sent the case to the CJEU to rule on how the threshold should be interpreted.

The UK government said that this clarifies the situation for manufacturers, importers and users, and lets laboratories know what needs to be tested and at what levels.

"The presence of a substance registered under REACH at a concentration of 0.1% in a minor component of a product will therefore be at a significantly lower concentration in the overall product, which will require laboratories to have validated procedures in place to measure these substances at the appropriate concentrations with an acceptable measurement uncertainty," a statement from the Government Chemist said.

Environmental law expert Helen Peters of Pinsent Masons, the law firm behind said: "It’s welcome to have clarity after the years of uncertainty on the subject. However there are still on-going issues of a similar nature outstanding with REACH that continue to present challenges for industry and commerce."

REACH regulations are managed by the European Chemicals Agency (ECA).