REACH – ECHA publishes further clarifications on restrictions: relevance for criminal liability risks

The European Chemicals Agency (ECHA) published further clarifications in late April on individual restrictions under Annex XVII to Regulation (EC) No. 1907/2006 (REACH). The clarifications can be found in the Q&As section of the ECHA website and relate to restrictions on:

• Lead carbonates and lead sulphate in paint (No. 16, No. 17 in Annex XVII of REACH)
• Mercury in medical thermometers and measuring instruments(No. 18a in Annex XVII of REACH)
• Cadmium and its compounds (No. 23 in Annex XVII of REACH)
• Pyrophoric liquids/solids or flammable gases/liquids/solids (No. 40 in Annex XVII of REACH
• Azocolourants and azodyes (No. 43 in Annex XVII of REACH)
• Nonylphenol and nonylphenol ethoxylates (No. 46 in Annex XVII of REACH)

In addition to more general clarifications, the recent explanations provided by the ECHA aim primarily to specify terms not previously defined in the REACH Regulation to determin the scope of the restrictions. Here the ECHA has drawn on term definitions borrowed from other areas of regulation.

Inclusion of other term definitions

Regarding the restriction of the use of lead carbonates and lead sulphates in paint, the ECHA has clarified that the term “paint” also covers artists’ paints or paint in DIY decoration sets for textiles. The ECHA’s reasoning is based on the definition of the term “paint” in the Commission’s decision to define the environmental criteria for awarding the EC environmental seal for interior paints and varnishes (2009/544/EC), which defines “paint” as a liquid, paste-like or powdered pigment-containing coating substance which when applied to a base forms a covering film with a protective, decorative or particular functional effect. The explicitly declared extension of the restriction to decoration sets is noteworthy, especially since the Commission’s decision expressly covers only the product group of “interior paints and varnishes”, i.e. products for DIY use and by professional painters, floor coatings and paints, decorative paints, primers or undercoats. However, this does not justify the inclusion of artists’ materials or DIY decoration sets for textiles.

Regarding the restriction of the use of mercury in measuring devices, the ECHA explains that the term measuring instrument (beyond the instruments listed in the restriction itself) can be defined on the basis of the provisions of Directive 2004/22/EC on measuring instruments. The ECHA refers in this context explicitly to the interpretation of the CEN. The ECHA also stresses that from this only the basis for understanding the term “measuring instrument” under No. 18a Annex XVII of REACH can be deduced. This makes it clear that in the ECHA’s view the scope of application of the restriction is not limited only to the measuring instruments covered by Article 1 and Article 3 of Directive 2004/22/EC.

Regarding the restriction of nonylphenol and nonylphenol ethoxylates, the ECHA clarifies that the term used there, “other body care products”, is to be understood as a more general term in relation to the cosmetic products which are also covered. Therefore the term “other body care products” covers in any case, but not only, all products meeting the definition of a “cosmetic product” under Article 2(1) (a) of Regulation (EC) No. 1223/2009.

Further clarifications

Besides the above clarifications of individual terms, in two cases the ECHA provides additional explanations with respect to the basic understanding of the restrictions.

For example, the ECHA specifies that plastic-coated metal beads for making jewellery are doubly covered by the restriction on cadmium. Regarding the plastic coating, the rules of No. 23 Fig. 1 of Annex XVII of REACH must be observed, while the metal beads themselves are covered by the requirements No. 23 Fig. 10 (i) of Annex XVII of REACH. Therefore a threshold of 0.01% by weight must be observed for both materials.

In relation to azocolourants, the ECHA explains that the restriction of No. 43 Fig. 3 of Annex XVII of REACH does not apply to imported products which were dyed outside the EU using appropriate substances or mixtures. But imported products still have to meet the requirements of No. 43 Fig. 1 and 2 of Annex XVII of REACH and may therefore only be marketed if these requirements are met.

Implications in practice

The ECHA is still keen to clarify the scope of application of the restrictions by means of additional explanations. For companies concerned, this is certainly worth noting, since breaches of the restrictions in Annex XVII of REACH are treated as criminal offences in Germany under Section 5 Chemical Penalties Regulation (ChemSanktionsV). In practice, the ECHA’s explanations are therefore very important in relevant criminal proceedings. Also, in 2016 official enforcement focuses in particular on inspecting products for compliance with the restrictions in Annex XVII of REACH.

Affected companies should therefore think carefully about whether they need to make any improvements in product compliance to avoid the risk of penalties.