1. Home
  2. |Insights
  3. |European Trade Union Confederation proposes list of 306 hazardous chemical substances for regulation under REACH

European Trade Union Confederation proposes list of 306 hazardous chemical substances for regulation under REACH

Client Alert | 4 min read | 04.09.09

On March 31, 2009, the European Trade Union Confederation ("ETUC") published a list of 306 substances that it believes should be placed on both the Candidate List of substances of very high concern ("SVHCs") and the Authorization List, both of which are regulated under the EU's chemicals legislation: the Regulation on the Evaluation, Authorization, and Restriction of Chemicals ("REACH"). ETUC's list follows the publication, by the NGO ChemSec on September 23, 2008, of the Substitute It Now ("SIN") list of 287 chemicals (for details see the Crowell & Moring client alert: S.I.N. List Proposal For The Replacement of 267 Chemicals in The EU). Although not legally binding, both ETUC's list and the SIN list are likely to have significant implications for any EU or non-EU company that either (i) manufactures in or exports to the EU a substance or a product containing a substance that is on one of the lists, or (ii) is a supplier, downstream user, or distributor for any of the companies covered by point (i).

ETUC's list includes 89 substances that are covered by the SIN list and, combined, both lists cover 484 substances. However, whereas the SIN list is centered around environmental and consumer concerns, ETUC's list focuses more on workplace issues and substances that have links to occupational diseases. ETUC's starting point is all substances produced or imported into the EU in quantities greater than 1,000 tonnes/year - 2,782 substances. ETUC then removed substances not eligible for inclusion in the Candidate List and ranked the remainder based on their danger to the health and the environment. Acrylamide was considered the most dangerous in view of its hazardous properties.

The 484 substances on both lists is in stark contrast to the much smaller three current official lists, which include:

  1. the 7 substances on the current Registry of Intentions for placement on the Candidate List;
  2. the 15 substances that the EU authorities placed, on October 28, 2008, on the current Candidate List of SVHCs; and
  3. the draft priority list of 7 substances the EU authorities selected, from the list of 15 on the Candidate List, to be placed on the Authorization List (for details, see a previous Crowell & Moring client alert: Recent developments in EU chemicals policy: ozone-depleting substances, packaging and labeling of chemicals, and REACH).

If a substance is placed on the Candidate List and/or the Authorization List there are certain legal obligations imposed on companies, including:

  • if a substance is on the Candidate List,
    • suppliers are required to provide professional users with a substance's safety data sheet;
    • consumers have the right to ask about the presence in products of any chemical on the Candidate List, with a 45-day deadline for a reply, and
    • companies producing or importing articles containing the SVHCs in the Candidate List above a certain concentration threshold will be required to notify the European Chemicals Agency ("ECHA");
  • if a substance is placed on the Authorization List, businesses will no longer be able to produce or use that substance unless they comply with stringent criteria, including demonstrating that the risks resulting from the use of a substance are adequately controlled, or that the socioeconomic benefits of the use outweigh the risks and there are no suitable alternatives.

Unlike the placement of a substance on the Candidate and Authorization Lists, there are no legal obligations resulting from a substance being placed on one of the non-mandatory lists (such as the ETUC or SIN lists); however, companies should still be concerned about non-legal consequences, notably the following:

  • companies producing consumer products (e.g. paints, perfumes and cleaning products) are already being put under pressure by consumers to switch suppliers to those that do not have raw materials containing substances on these "non-mandatory" lists. In many cases, companies producing consumer products may find it difficult to justify the presence of a substance on a list in their products and they may be forced, for marketing reasons, to use suppliers that produce substitute substances, even if changing suppliers causes business disruptions;
  • NGOs, and even some Member States if they are in favor of restricting the use of substances on a non-mandatory list and disappointed with the relatively small amount of substances currently on the Candidate List, may use the non-mandatory lists to exert their own pressure on companies to cease using these substances; and
  • in view of the two previous points, companies towards the bottom of the supply chain are likely to be requesting more detailed information, about the substances and mixtures ("preparations") contained in a product that they sell, from companies higher up the supply chain - thereby even if a non-EU company is not directly affected by a list, if it is a supplier it may find that it is being subjected to requests for information from (EU) companies lower down its supply chain.

Furthermore, the presence of a product on one of the non-mandatory lists is likely to be viewed with great interest by the European Commission and the EU Member States who regularly analyze and decide which substances should be added next to the Registry of Intentions for eventual placement on the Candidate and Authorization Lists. Therefore, companies with an interest in any of the substances on the non-mandatory lists would be well advised to watch carefully as to whether any of these substances are then placed on the Registry of Intentions and to take legal advice accordingly.

Insights

Client Alert | 4 min read | 05.07.24

Life Finds A Way: The FDA Releases Draft Guidance for Labeling and Advertising Biological and Biosimilar Products

The Food and Drug Administration (FDA) has published revised draft guidelines in the Federal Register on promotional labeling and advertising considerations for the biologic and biosimilar industry, updating guidance from 2020. The quick revisions emphasize the fast-changing and rapidly growing nature of this industry....