ECHA Seeks to Add 18 Substances to Annex XIV of REACH

The ECHA has suggested adding 18 substances, mostly chemicals used as stabilizers and solvents, to Annex XIV (Authorization List) of REACH. Comments on the suggestion can be made until December 5 as part of a public consultation. The agency specifically selected the candidates based on the information in their registration dossiers about their use and quantities.

The materials include the following chemicals with reprotoxic properties (including examples of their use):

  • bisphenol A: an endocrine disruptor used in epoxy resin hardeners
  • 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia4-stannatetradecanoate (DOTE): stabiliser in pol-ymers
  • reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4- octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE): stabiliser in polymers
  • dioxobis(stearato)trilead: stabiliser in PVC
  • fatty acids, C16-18, lead salts: stabiliser in PVC
  • trilead dioxide phosphonate: stabiliser in PVC, rubber production, mirror backing
  • sulfurous acid, lead salt, dibasic: stabiliser in PVC; mirror backing
  • [phthalato(2-)]dioxotrilead: stabiliser in PVC
  • trilead bis(carbonate) dihydroxide: artists’ paints
  • lead oxide sulfate: mirror backing
  • tetraethyllead: additive in aviation fuel
  • 2-methoxyethanol: solvent
  • 2-ethoxyethanol: solvent

Two substances, dicarboxylic anhydrides HHPA und MHHPA, irritate the respiratory system. They are used as hardeners in epoxy resins.

The chemicals listed by the ECHA also include dechlorane plus, a very persistent and very bioaccumulative (vPvB) chemical used as a flame retardant in adhesives and polymers. It is also looking at the reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde, and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl). It is used in lubricants and greases but is an endocrine disruptor.

In addition, the ECHA wants to include 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2), which is used in printing inks, but its carcinogenic qualities are disputed.

As part of the consultation, the agency is asking for further information on the uses of the substances along with information on the structure and complexity of the supply chains.

After the consultation ends on December 5, the Member State Committee (MSC) of the ECHA will review all position papers and prepare its recommendation. Based on the draft, the ECHA will make its final recommendation to the EU, which has the last word. Ultimately, it decides which chemicals appear in the Authorization List and under what conditions.

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REACH Dossier Updates: EU States Propose Implementing Regulation

Along with Norway, three member states of the EU, France, Netherlands, and Hungary, have called for regular, obligatory updates of REACH dossiers and argued strongly for an implementing regulation. They formulated their position in special papers submitted after a discussion of 5 of the 16 REACH review actions at the June meeting of Competent Authorities for REACH and CLP (CARACAL). They argue that the proposal would not define any new obligations, but simply explain the existing ones. The central point is to clarify the conditions set forth in Article 22.

The article states that after each registration, the registrant is responsible, “on his own initiative” and “without undue delay”, for updating the registration based on relevant new information and to transmit the information to the agency. Nevertheless, the text clearly leaves room for interpretation, so that many companies update their registrations only after an express request from the ECHA.

According to the argument made by France, companies should be obligated to review their registrations from time to time. Companies should be able to document the performance of a routine review in IUCLID in cases where an update is unnecessary. Along with France, the other three member states regard an implementing regulation as the pragmatic solution.

The four countries are not alone in their concern. Both industry associations, the Downstream Users of Chemicals Coordination Group (DUCC) and Eurometaux, support mandatory updates according to Article 22. For example, Eurometaux calls for a “clear and systematic process” for updating dossiers. The association also suggested a checklist that could help companies in consortiums determine when an update is necessary. Sample items in the checklist include:

  • Substance identity profiles (for new registrants)
  • Hazard profiles and classifications for humans and the environment
  • New scientific findings that lead to changes in classification, safety data sheets, and chemical safety reports

The executive director of the ECHA, Bjorn Hansen, has also identified Article 22 as a weakness. In a speech at the REACH Review Conference in June, he admitted that REACH is weak in terms relation to registration updates. As early as September 2017, a report sponsored and published by the agency stated that new regulatory measures must ensure that updates occur at regular intervals – every three years, for example.

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Brexit: VCI Urges Preparations for Failed Negotiations

Utz Tillmann, the chief executive of the German Chemical Industry Association (Verband der Chemischen Industrie: VCI), has urged solution-oriented negotiations between the EU and Great Britain and emphasized the importance of linking the country to the EU’s chemicals agency ECHA. Otherwise, he stated, chaos threatens to reign over the exchange of goods between the EU and Great Britain, or, in the worst case, come to a complete stop. “The payment of duties and time-consuming customs procedures at the border could bring numerous supply chains to a standstill, as could suddenly missing registrations and approvals for chemical products from Great Britain. Our customers would be seriously affected,” said Tillman in a press release issued in August. For safety’s sake, he added, companies should prepare for a Brexit without an agreement on the post-Brexit situation.

But how can preparations be made when the context is not even remotely clear? Great Britain has published a white paper that describes what the solution could look like. The European Council will issue a statement on the status of the negotiations in mid-October, regardless of the situation at that time. Both the EU and the British government have prepared for a failure of negotiations. An important factor here is the British Health and Safety Executive (HSE). It has stated that it could take over most of the tasks now performed by the ECHA. Such elements include part of the Plant Protection Products Regulation, REACH, and the IT infrastructure required for the registration and regulation of chemical substances.

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California Approves Labeling Requirement for Cosmetics

California has enacted a law (AB 2775) that requires cosmetics manufacturers to list all ingredients on the labels of their products, including cosmetics used in manicures, hair salons, and other cosmetic and beauty salons. The law goes into effect on July 1, 2020. The previously applicable law applied only to retail cosmetics, not to the special cosmetics used in salons.

According to California’s State Board of Barbering and Cosmetology, more than 129,000 manicurists and 312,000 cosmetologists are licensed for nail and hair care in the state. The law helps the owners of salons choose products more safely and thus better protect themselves and their customers from any harmful effects.

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German App Clarifies the Spread of Per- and Polyfluorinated Substances (PFCs)

The German Environment Agency has published an app (PFC-Planet) that highlights the problem of per- and polyfluorinated substances (PFCs). The app shows how the substances enter the environment and the food chain, what the consequences for us are, and what we can do about it. Video, animated graphics, and short, informative texts give users a quick overview. Users can also test their knowledge with a quiz.

Because PFCs are highly resistant to heat, stains, grease, and water, they are used in a wide variety of products, including textiles, paper, and extinguishing agents. The crux of the problem is that PFCs enter human beings in food or through the air and accumulate in the body. They are persistent, bioaccumulative, and toxic. The most familiar include perfluorinated carboxylic acid (PFCA) and perfluorooctanesulfonic acid (conjugate base perfluorooctanesulfonate: PFOS). As of July 4, 2020, PFCA may not be manufactured or marketed in the EU. For more information, please see our blog.

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Columbia Implements Sixth Edition of GHS

The Columbian Labor Ministry is looking toward mandatory implementation of the sixth edition of the Globally Harmonized System (GHS) for the classification and labeling of chemicals. It issued a decree to that effect on August 6. The implementation is the result of Columbia’s entry into the Organization for Economic Co-operation and Development (OECD).

Decree 1496 (Spanish only) regulates the manufacture, import, storage, transport, distribution, marketing, and use of chemical substances and mixtures. The document also defines the responsibilities of each actor in the chemical supply chain.

In the next step, the Ministries of Labor, Agriculture, Transportation, and Health will now set the schedule and transition periods for:

  • Chemical products in the workplace
  • Agricultural pesticides
  • Transport of chemical products
  • Consumer chemical products

In November 2017, Columbia announced its plans to implement GHS. It joined OECD at the end of May, which obligated it to implement the GHS regulations. At the beginning of this year, researchers in Sweden and the Netherlands studied the global implementation of GHS standards and uncovered significant gaps.

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REACH and CLP: Dutch Study Uncovers Regulatory Gaps

The materials data required by REACH is insufficient for a correct assessment of the dangers that such chemicals pose and a valid classification according to the CLP regulation. That’s the finding of scientists at the Dutch National Institute for Public Health and the Environment (RIVM) developed as part of a study. Potential mutagens and carcinogens pose a particular problem.

In their article in Human and Ecological Risk Assessment: An International Journal, the authors criticize the current situation in which both regulations require different data because the clinical studies have different end points. In CLP for example, classification of a material as a 1B mutagen must be substantiated by somatic in vivo germ cell tests in mammals or humans. REACH, however, requires only in vitro studies. Only in exceptional cases does it ask registrants to consider germ cell tests, but such tests are not mandatory. The authors note that because the tests require a great deal of time and expense, it is unlikely that registrants will perform them voluntarily.

Theoretically, the data gaps can be closed within the REACH substance evaluation process (German only), and member states could make in vivo tests mandatory. Nevertheless, the entire process lasts up to seven years. The RIVM scientists therefore suggest three solutions:

  • Modifying REACH to require in vivo mutagen and carcinogen studies
  • Changing the CLP criteria to accept in vivo evidence for classification in Category 1B.
  • Lowering the REACH criteria for the classification of substances of very high concern (SVHC) to include carcinogens and mutagens of Category 2

The authors also state that all these measures require “considerable time and political will”. But they note that the primary goal of their study was not to find fixes, but to serve as a first step toward identifying the discrepancy between REACH and CLP and to trigger an overdue discussion of the matter.

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