E.U. chemical developments we’re expecting in October 2023
Welcome to AgencyIQ’s roundup of regulatory activities anticipated next month in the European Union chemicals sector. This ongoing feature compiles public information from across E.U. agencies and institutions to deliver insight into what chemicals-related regulatory actions are likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. This targeted intelligence seeks to save subscribers’ time and help mitigate the information-overflow challenge that policy and regulatory affairs professionals face every day.
Key regulatory actions on the horizon
- The renewal of approval of glyphosate. The European Commission’s Standing Committee on Plants, Animals, Food and Feed (PAFF) may vote to renew the approval of the controversial herbicide at its October 12-13 meeting, after the European Food Safety Authority (EFSA) issued peer-review conclusions in July, finding no areas of critical concern. The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. The draft legislation approves glyphosate for a further 10-year period. The current approval expires December 15 of this year.
- CLP revision. On October 5, the European Parliament (EP) plenary is scheduled to debate and likely vote on its position on the proposed regulation for reforming Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The action will clear the path for the start of trilogue negotiations with the Council of the E.U., which concluded its position on the proposal last June. [For an in-depth analysis of the EP’s amendments see this AgencyIQ article; for a closer look at the Council’s take on the Commission’s proposal, see this AgencyIQ piece.]
- Microplastics. The Commission is preparing to unveil a proposal whose main objective is to prevent the unintentional release of microplastics into the environment. At an exchange of views with European lawmakers on September 11, Environment Commissioner Virginijus Sinkevičius stated that this legislation was “more or less ready.” The proposal is expected to introduce some combination of legally binding measures like labeling, standardization, certification, and an extended producer responsibility (EPR) scheme to combat these substances.
- Elements of the Chemicals Strategy for Sustainability (CSS). Two proposals under CSS – one aimed at enhancing access to chemicals data by removing technical and administrative obstacles and the other intended to promote a “one substance, one assessment” process for chemical safety assessments – appear close to being adopted by the Commission.
- Update on the universal restriction on PFAS. The public consultation on the proposed blanket restriction on per- and polyfluoroalkyl substances (PFAS) closed on September 25. Now comes the next step in the REACH restriction process, the assessment of the proposal as documented in the opinions of ECHA’s risk assessment and socio-economic analysis committees (RAC and SEAC). However, given the unprecedented high level of input from stakeholders during the consultation, these opinions aren’t expected to be finalized until sometime in the first half of next year.
Chemicals legislation we expect the European Commission to adopt any day
- The European Commission is responsible for drafting legislation under E.U. law. Below is a list of the proposed legal acts that the Commission is due to adopt and make publicly available on its “Have your say” initiatives portal.
- Under ordinary legislative procedure (OLP), once adopted, a Commission proposal is submitted to the E.U.’s co-legislators, the Council, and the EP. Each, in turn, takes up the proposed legislation for discussion, possibly amends it, and adopts a position on the (amended) proposal. It can only be finalized and, subsequently, published in the Official Journal of the EU if the co-legislators are able to come to an agreement on the final text and adopt the common version agreed to by both institutions.
- An important caveat: The adoption timeframes which the E.U. executive indicates on the “Have your say” portal are not always followed strictly and may be subject to delay.
| Planned legislation | Description | Type of act | Link |
|
Chemical safety – better access to chemicals data for safety assessments Adoption was planned for first quarter of 2023 |
This initiative aims to improve access to chemicals data by removing technical and administrative obstacles. This is based on the principles that data should be easy to find, share and reuse, as well as be interoperable and secure. The initiative will make it easier to access and use all available data and will increase transparency. It will also enable E.U. and national authorities, where necessary, to commission testing and monitoring of chemical substances as part of the regulatory framework. |
Proposal for a regulation | Initiative entry |
|
Chemicals – making best use of E.U. agencies to streamline scientific assessments Adoption was planned for second quarter of 2023 |
The European Green Deal aims to move towards a “one substance, one assessment” process for chemical safety assessments. Streamlining E.U.-level scientific and technical work on chemicals by making best use of the relevant E.U. agencies’ expertise will considerably contribute to achieving this. This initiative will: |
Proposal for a regulation | |
|
Microplastics pollution – measures to reduce its impact on the environment Adoption was planned for second quarter of 2023 |
This initiative aims to tackle microplastics unintentionally released into the environment. It will focus on labeling, standardization, certification, and regulatory measures for the main sources of these plastics. It aims to: |
Proposal for a regulation | |
|
E.U. chemicals strategy for sustainability – Cosmetic Products Regulation (revision) Adoption was planned for fourth quarter of 2022 |
The E.U. chemicals strategy for sustainability aims to better protect human health and the environment as well as boost innovation for safe and sustainable chemicals. This initiative focuses on cosmetic products, in particular on various actions and potential measures to improve the efficiency and effectiveness of the current rules on cosmetic products. |
Proposal for a regulation | Initiative entry |
|
Animal welfare – Animals used for scientific purposes (adaptation of standards on care, accommodation and killing) Adoption is planned for third quarter of 2023 |
The initiative is to adapt two annexes of Directive 2010/63/EU on the protection of animals used for scientific purposes: The changes include standards for species currently not covered by the annexes but within the scope of the Directive. |
Proposal for a directive | Initiative entry |
|
Preventing terrorism – new rules on the marketing and use of high-risk chemicals Adoption is planned for third quarter of 2023 |
This initiative establishes rules on the marketing and use of high-risk chemicals. It aims to increase security in the E.U. by reducing the risk of dangerous chemicals being acquired by terrorists or other criminals to carry out attacks. |
Proposal for a regulation | Initiative entry |
|
Revision of E.U. rules on food contact materials Adoption was planned for second quarter of 2023 |
E.U. food safety policy includes rules on food contact materials (e.g., food packaging, kitchen and tableware and food processing equipment). This initiative aims to modernize the rules to: |
Proposal for a regulation | Initiative entry |
|
Safe detergents – updated rules Adoption was planned for first quarter 2021 |
Detergents – cleaning products containing soaps and similar active agents – can contain ingredients that may damage water quality when released into the environment. E.U. rules ensure detergents in both household and industrial use are safe and sustainable. Following an evaluation, this initiative: |
Proposal for a regulation | Initiative entry |
|
Persistent organic pollutants – dechlorane plus Adoption planned for fourth quarter of 2023 |
Regulation (EU) 2019/1021 on persistent organic pollutants implements the E.U.’s international commitments under the Stockholm Convention on persistent organic pollutants (chemical substances). Following a decision to add dechlorane plus to the Convention, this initiative amends Annex I to the Regulation to include dechlorane plus as a substance subject to certain restrictions. | Proposal for a regulation | Initiative entry |
|
Persistent organic pollutants – UV-328 Adoption planned for fourth quarter of 2023 |
Following a decision to add UV-328 to the Convention, this initiative amends Annex I to the Regulation to include UV-328 as a substance subject to certain restrictions. | Proposal for a regulation | Initiative entry |
|
Persistent organic pollutants – methoxychlor Adoption planned for fourth quarter of 2023 |
Following a decision to add methoxychlor to the Convention, this initiative amends Annex I to the Regulation to include methoxychlor as a substance subject to certain restrictions. | Proposal for a regulation | Initiative entry |
|
Persistent organic pollutants – PFOS limits and exemptions Adoption was planned for first quarter of 2023 |
Perfluorooctanesulfonic acid (PFOS) and its derivatives are listed in Annex I to Regulation (EU) 2019/1021. This measure will reduce the maximum PFOS concentration allowed as unintentional trace contaminant in substances, mixtures and articles and will remove the last specific exemption allowed in the E.U. since it is no longer needed. |
Proposal for a regulation | Initiative entry |
|
Persistent organic pollutants – hexabromocyclododecane (HBCDD) Adoption was planned for first quarter of 2022 |
This act concerns HBCDD (included in Annex I of Regulation (EU) 2019/1021). It amends the limit value for the presence of HBCDD as an unintentional trace contaminant in substances, mixtures and articles. | Proposal for a regulation | Initiative entry |
|
Persistent organic pollutants – polybrominated diphenyl ethers (PBDEs) Adoption was planned for first quarter of 2022 |
This act concerns PBDEs (included in Annex I of Regulation (EU) 2019/1021). It amends the limit value for the presence of PBDEs in mixtures or articles. | Proposal for a regulation | Initiative entry |
|
Review: Restriction of the use of hazardous substances in electronics Adoption was planned for fourth quarter of 2022 |
E.U. rules limit the use of certain harmful substances in electrical and electronic equipment to protect human health and the environment and ensure proper functioning of the internal market. The initiative is intended to simplify and increase the efficiency of the current rules and improve their enforcement. | Proposal for a directive | Initiative entry |
|
Hazardous substances in electrical and electronic equipment – list of restricted substances (update) Adoption planned for fourth quarter 2023 |
Following a technical assessment, this initiative proposes adding tetrabromobisphenol A (TBBP-A) and medium-chain chlorinated paraffins (MCCPs) to the list of restricted substances. | Proposal for a directive | Initiative entry |
|
Hazardous substances in electrical and electronic equipment – exemption for cadmium in quantum dots for LED applications Adoption was planned for second quarter of 2023 |
Under EU rules, certain hazardous substances cannot be used in electrical and electronic equipment. Businesses can request exemptions where the substance cannot (yet) be replaced. The Commission has assessed three exemption requests on the use of cadmium in quantum dots in LED lighting and displays. This initiative proposes amending the list of restricted substances in Annex III to Directive 2011/65/EU. |
Proposal for a directive | Initiative entry |
|
Hazardous substances – exemption for use of lead to create superconducting magnet circuits in specific devices Adoption was planned for third quarter of 2021 |
This initiative allows lead to be used in metallic bonds to create superconducting magnetic circuits in superconducting quantum interference device (SQUID) detectors. | Proposal for a directive | Initiative entry |
European Chemicals Agency (ECHA) consultations closing in October
ECHA: Identification of substances of very high concern (SVHC)
- Interested parties are invited to provide feedback by the deadline given below on the chemicals put forward for identification as SVHCs. Once identified as SVHCs, these chemicals are added to the Candidate List for eventual inclusion in REACH Annex XIV, i.e., the Authorization List.
- Click on the substance name to be taken to its corresponding entry where the link to give comments can be accessed.
| Name | CAS RN | Reason for proposing as SVHC (per article 57 of REACH) | Deadline |
| 2,4,6-tri-tert-butylphenol | 732-26-3 | Toxic for reproduction (Article 57c); Persistent, bioaccumulative, toxic (PBT) (Article 57d); Very persistent, very bioaccumulative (vPvB) (Article 57e) |
October 16, 2023 |
| 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol | 3147-75-9 | vPvB (Article 57e) | October 16, 2023 |
| 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one | 119344-86-4 | Toxic for reproduction (Article 57c) | October 16, 2023 |
| Bumetrizole | 3896-11-5 | vPvB (Article 57e) | October 16, 2023 |
| Dibutyl phthalate | 84-74-2 | Endocrine disrupting properties (Article 57(f) – environment) | October 16, 2023 |
| Oligomerization and alkylation reaction products of 2-phenylpropene and phenol | Not provided (EC No. 700-960-7) | vPvB (Article 57e) | October 16, 2023 |
ECHA: Harmonized classification and labeling (CLH)
- Consultations on classification and labeling harmonization (CLH) are open for 60 days and seek to elicit feedback from all interested parties on the hazard classes proposed by the dossier submitter, as well as on those that were not concluded to warrant classification.
- Click on the substance name below to be taken to its corresponding entry on ECHA’s website where the link to comment can be accessed.
| Name | CAS RN | Hazard classes open for commenting | Deadline |
| 3,4-dimethyl-1H-pyrazol-1-ium dihydrogen phosphate | 202842-98-6 | Acute toxicity – inhalation Acute toxicity – dermal Acute toxicity – oral Reproductive toxicity Specific target organ toxicity — repeated exposure |
October 13, 2023 |
| 3,4-dimethyl-1H-pyrazole | 2820-37-3 | Acute toxicity – inhalation Acute toxicity – dermal Acute toxicity – oral Carcinogenicity Reproductive toxicity Specific target organ toxicity — repeated exposure |
October 13, 2023 |
| 3,5-dimethylpyrazole | 67-51-6 | Acute toxicity – oral Reproductive toxicity Specific target organ toxicity – repeated exposure |
October 13, 2023 |
|
ulexite (CaNaH12(BO3)5.2H2O) [1]; ulexite (CaNaH12(BO3)5.2H2O), calcined [2](- [1];296-662-5 [2]) |
1319-33-1 92908-33-3 1318-33-8 854267-07-5 92908-12-8 12045-88-4 |
Reproductive toxicity | October 13, 2023 |
| rape oil; rape seed oil | 8002-13-9 | Explosives Flammable liquids Self-reactive substances and mixtures Pyrophoric liquids Self-heating substances or mixtures Substances or mixtures which in contact with water emit flammable gases Oxidising liquids Organic peroxides Corrosive to metals Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity — single exposure Specific target organ toxicity — repeated exposure Aspiration hazard Hazardous to the aquatic environment |
October 13, 2023 |
ECHA: Applications for authorization (AfAs)
- Each application for authorization under REACH involves an eight-week public consultationinviting interested third parties to provide information on alternative substances or technologies for the uses of the Annex XIV substances included in the AfA. Below is an overview of the AfAs currently being consulted on, listed according to substance and number of corresponding AfAs.
- For links to each individual AfA consultation, including specific uses being applied for and the names of applicants, see ECHA’s dedicated page here.
| Name | CAS RN | Number of AfAs | Deadline |
| Chromium trioxide | 1333-82-0 | 24 | October 11, 2023 |
| Dichromium tris(chromate) | 24613-89-6 | 1 | October 11, 2023 |
| Potassium dichromate | 7778-50-9 | 6 | October 11, 2023 |
| Sodium chromate | 7775-11-3 | 2 | October 11, 2023 |
| Sodium dichromate | 10588-01-9 | 10 | October 11, 2023 |
ECHA: Testing proposals
- Testing proposals are subject to 45-day consultations during which third parties are invited to submit relevant scientifically valid information and studies addressing the substance and hazard endpoint(s).
- To contribute relevant information, click the substance name below to be taken to its corresponding entry where the links to give comments on individual hazard endpoints can be accessed.
| Name | CAS RN (or EC No.) |
Number of hazard endpoints for which vertebrate testing proposed | Deadline |
| 3,4-dihydroxy-1-[(Z)-octadec-9-enyl]pyrrolidine-2,5-dione | 700-233-4 | 3 | October 19, 2023 |
| 3-mercaptopropionic acid | 107-96-0 | 2 | October 19, 2023 |
| Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, magnesium salts, magnesium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50 | 701-469-0 | 1 | October 19, 2023 |
| Reaction mass of 1-methyl-4-(1-methylethylidene)cyclohexyl acetate and p-menth-1-en-8-yl acetate | 904-693-9 | 1 | October 19, 2023 |
| Reaction mass of 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde | 915-650-9 | 2 | October 19, 2023 |
| Styrene | 100-42-5 | 1 | October 19, 2023 |
ECHA webinars and other events in October
- Online events hosted by ECHA are free to attend and, unless otherwise stated, are typically broadcast live on the agency’s website.
| Event title | Date | Related link |
| Towards faster regulatory action: ECHA’s approach to assessing chemicals in groups | October 3, 2023, 11 am – 1 pm EEST (GMT +3) | ECHA webpage |
| New ECHA public Data availability system – Part II | October 19, 2023, 11 am – 12 pm EEST (GMT +3) | ECHA webpage |
| Online training session SPC-IUCLID for industry users (Note: You must register before October 6 to participate in this event) | October 24, 2023, 9 am – 15 pm EEST (GMT+3) | ECHA webpage |
To contact the author of this analysis, please email Scott Stephens.
To contact the editor of this analysis, please email Patricia Iscaro.