EU: Criteria for Endocrine Disruptors Also Apply to Biocides

On September 4, the EU Commission accepted scientific criteria to determine endocrine disruptors for biocides. The EU has published a press release that contains several useful links. The EU Parliament and Council now have two months to study the planned text. In July, the members had already approved acceptance of the criteria for plant protection products. That approval opens a path for harmonization of EU law on plant protection products and biocides.

As soon as the law takes effect, substances that affect endocrines will no longer be approved. Exceptions are possible only in cases of negligible exposure, and then the ingredients can be approved with limitations.

The World Health Organization (WHO) defines endocrine disruptors as substances or mixtures that influence the hormonal system. They affect not only the health of a specific organism, but also its descendants. If you are interested in more details about the topic, please see the FAQ list provided by the commission.

We have helped our clients for many years win approval of biocides according to the requirements of Biocide Regulation (EU) Nr. 528/2012). We provide advice and accompany them throughout the entire process, execute registrations, direct the accompanying studies, create dossiers, offer project management, and manage communication with regulatory agencies. Please contact us at

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EU Commission Modifies Cosmetics Regulation

The EU Commission has published amendments to the Cosmetics Regulation and banned the use of three fragrances (3 and 4-(4-hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC), atranol, and chloratranol) in cosmetics.

As early as 2012, the Scientific Committee on Consumer Safety (SCCS) had indicated that of all allergenic fragrances, these three substances had triggered the largest number of contact allergies in the preceding few years.

The EU Commission reacted appropriately and decided that as of August 23, 2019, cosmetics that contain one or more of these substances may no longer be placed on the market. Furthermore, as of August 23, 2021, cosmetics that contain one of more of these substances may not be made available within the EU.

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ECHA Publishes Updated Guidance for Substances in Articles

The ECHA has published version 4.0 of its Guidance on requirements for substances in articles as a response to a decision of the European Court of Justice (ECJ) in September 2015. At that time, the court decided that the information requirements for substances of very high concern (SVHC) in articles according to Article 7 Sections 2 and 33 of REACH did not relate to the product sold or bought, but to all the parts used in a composite product, such as a bicycle or automobile. We reported on the decision and its background in our blog entry: SVHC: Court of Justice of the European Union Contradicts the ECHA.

In an overview published in REACH plus (German only), legal expert Hartmut Scheidmann highlighted the weaknesses of the update guidance. For example, the authors use a new term, “complex objects.” The term describes an article that consists of several subassemblies. Yet, as Scheidmann criticizes, REACH itself uses only the term “article.” Legally, says Scheidmann, the new term opens the door to misunderstandings. In Chapter 5 and Appendix 5, the authors of the document also speak of the obligations of the purchasers of articles to inform themselves about the presence and contents of SVHC. But as Scheidmann points out, Article 33 of REACH states that the vendor must proactively supply this information. In his conclusions, he writes that the guidance fails to live up to legal stipulations and to clarify many open questions. Nevertheless, he adds, companies are on the safest side when they adhere to the guidance despite all its weaknesses.

You can read the press release issued by the ECHA announcing the publication of the guidance here.

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GHS: The Ultimate Overview

In July, the United Nations Economic Commission for Europe (UNECE) published an updated edition of GHS Guidelines. The compendium is updated every two years. It is an instrument designed to help the international community of nations advance harmonization of the classification and labeling of chemicals.

It’s important to know that the provisions of the guidelines are not necessarily legally valid. They go into effect only when individual countries implement them. In the European Union, for example, the CLP Regulation has the force of law.

You can order the new GHS Guidelines from the UNECE Web site.

Do you need support to follow the GHS Guidelines in your country? We are here for you at

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Industry Taking Requirements to Update REACH Dossiers Lightly

ECHA director Geert Dancet has criticized companies that do not meet their obligations to update REACH dossiers at all, or that do so inadequately. Such companies, he says, misunderstand Article 22 of REACH. Dancet made his comments in July during the annual meeting of the Committee for Environment, Public Health, and Food Safety (ENVI) of the European Parliament.

Article 22 states that registrants must proactively update their registrations in good time based on pertinent new information and then transmit the new information to the ECHA. Updates are required when any of the following occurs:

  • The status of the manufacturer or importer changes
  • The composition of the substance changes
  • The tonnage range of the substance changes
  • The substance is now being used in ways that Annex VI Section 3.7 discourages
  • Recognition of a substance’s risks leads to modifications of the safety data sheet or the chemical safety report
  • The classification and labeling of the substance changes
  • The content of the chemical safety report or of Annex VI Section 5 changes
  • A registrant’s determination that an experiment according to Annex IX or Annex X is to be performed
  • The accessibility of the information in the registration dossier changes

According to Dancet, companies should update their dossiers every five or ten years and pay the ECHA an appropriate fee.

Dancet’s deputy, Jukka Malm, made similar comments in the last ECHA report. See our report in our posting: Registration Dossiers: ECHA Calls for Regular Updates.

The ECHA undertook two projects between June 2016 and July 2017 to inspect the completeness of dossiers and encourage companies to supply any missing data. Among normal registrants, 35 of the requests were met and two approvals were rescinded because of missing data. More than 40 approvals given to lead registrants were inspected, but only one of them was rescinded. The ECHA reported on the projects in July.

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In the United States, Maine Bans Flame Retardants in Furniture Upholstery

At the beginning of August, the state of Maine issued a Law („An Act To Protect Firefighters by Establishing a Prohibition on the Sale and Distribution of New Upholstered Furniture Containing Certain Flame-retardant Chemicals, LD182) that prohibits the sale of furniture upholstery containing more than 0.1% of a flame retardant. The threshold value applies to individual substances and to mixtures. It takes effect on January 1, 2019.

Numerous groups of firefighters (including the professional firefighters of Maine) and NGOs (including Prevent Harm, the Silent Spring Institute, and the American Academy of Pediatrics) hailed the measure as groundbreaking. The groups regard flame retardants as responsible for the increasing rate of cancer among firefighters.

Opponents of the law, like Republican Governor Paul LePage, argued that not all flame retardants are harmful to health. They also felt that the measure was premature and preempted ongoing scientific studies.

Manufacturers and associations like the North American Flame Retardants Alliance (NAFRA) also criticized the law. They feel that flame retardants can protect citizens in fires and that prohibiting them endangers citizens.

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PFOA Ban: Early Norwegian Action Is Legal

In July, the court of the European Free Trade Association (EFTA)-ruled that Norway’s law banning perfluorooctanoic acid (PFOA) from consumer products and textiles is legal. The plaintiffs, the EFTA Surveillance Authority, had accused Norway of preempting the European-wide REACH law. The complaint states that Norway had violated Article 11 of the EEA Agreement that forbids states that have ratified the agreement from limiting any imports. According to the suit, only EU regulations are legally binding.

Norway had modified its product regulations as early as May 2013 and limited the use of PFOA. It based its decision on Article 128 (2) of REACH. The article allows a country to enact its own laws in cases “where REACH does not harmonize the requirements on manufacture, placing on the market, or use.”

In its judgement, the court stated that the application and use of PFOA in the EU was not at all regulated when the Norwegian law went into effect, so that a violation of REACH was impossible. Accordingly, no valid objections to the Norwegian law exist.

The EU Commission caught up with Norway only in June of this year and included PFOA in Annex XVII of REACH. The regulation grants companies a three-year period in which to react to the limitations.

PFOA is part of a group of per- and polyfluorinated chemicals (PFC). In September 2015, the German government replied to a parliamentary inquiry from Alliance Bündnis90/The Greens about the diffusion and dangers of PFC (German only).

If you have questions about PFOA and other substances subject limited use, please contact us at

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