Reproductive Toxicity

EU CLP – Swedish Chemicals Agency Supports RAC Opinions on Draft ATP 25 and Additivity Notes for Cyclamal and Bourgeonal Groups

Sweden’s Chemicals Agency has formally backed ECHA’s RAC opinions and the proposed harmonised classifications in the draft 25th Adaptation to Technical Progress to the EU CLP Regulation, including additive treatment of certain cyclamal and bourgeonal fragrance groups for reproductive toxicity. If these CLP changes are adopted, mixtures containing multiple substances from these groups may more often require classification and labelling as reproductive toxicants, tightening risk management obligations for EU chemical and product suppliers.

15 May 2026, 17:46circabc.europa.euEuropean UnionSweden

EU: ECHA Opens CLH Consultation On Harmonised Classification Of Cobalt Bis(2-Ethylhexanoate) (136-52-7)

In May 2026, ECHA opened an EU CLH consultation on a Dutch proposal to classify cobalt bis(2-ethylhexanoate) (CAS 136-52-7) as both Carc. 1B (H350) and Repr. 1B (H360FD) under the CLP Regulation, with comments due by 10 July 2026. If adopted, this harmonised CMR classification would require EU suppliers using this cobalt salt to align CLP labelling, safety data sheets, and mixture classification with the new Carc. 1B/Repr. 1B status and to reassess affected uses accordingly.

13 May 2026, 09:20echa.europa.euEuropean Union

GB HSE Article 37 Technical Report Proposes GB MCL Classification for Milbemectin

In April 2026 HSE, acting as the GB CLP Agency, published an Article 37 technical report that agrees with the EU RAC opinion and proposes a new GB mandatory classification and labelling entry for the plant protection active substance milbemectin, adding carcinogenicity, reproductive toxicity, STOT SE 1 and severe aquatic hazard classifications. Although the MCL has not yet been adopted, GB suppliers using milbemectin should anticipate more stringent classification and labelling duties and begin assessing portfolio, labelling and risk-management impacts ahead of eventual implementation.

11 May 2026, 19:02hse.gov.ukUnited Kingdom

ECHA Assessment of Regulatory Needs for 2,6-di-tert-butyl-p-cresol (BHT)

ECHA has issued a group Assessment of Regulatory Needs (ARN) for tert‑alkyl hindered phenols and created a dedicated ARN entry for 2,6‑di‑tert‑butyl‑p‑cresol (BHT), identifying it as part of a priority group with potential endocrine‑disrupting, reproductive and PBT/PMT concerns and widespread uses as an antioxidant in fuels, lubricants, plastics, coatings, adhesives and cosmetics. While no binding measure has yet been proposed, ECHA explicitly foresees harmonised classification followed by a REACH restriction if the hazards are confirmed, so companies using BHT at scale should monitor this file closely and consider substitution or risk‑reduction options in affected formulations and articles.

7 May 2026, 20:10echa.europa.euEuropean Union

ECHA Opens CLH Consultation on Metaldehyde (EC 203-600-2, CAS 108-62-3)

ECHA has launched an EU CLP public consultation on a proposed harmonised classification for the substance metaldehyde, open for comments from 4 May to 3 July 2026. The eventual CLH outcome will fix a uniform EU hazard profile for metaldehyde, shaping how manufacturers and downstream users classify, label, and communicate its risks across products and supply chains.

7 May 2026, 07:47echa.europa.euEuropean Union

EU SCCS Issues Preliminary Opinion on Acetophenone in Cosmetic Products

The EU Scientific Committee on Consumer Safety has issued a preliminary opinion finding acetophenone safe in cosmetic products when present at up to 0.01% (100 ppm), with consultation open until July 2026. Cosmetics manufacturers and ingredient suppliers using natural complex substances that contain acetophenone should expect this safety level to guide future updates to EU Cosmetics Regulation requirements and start checking formulations and exposure assessments against the 0.01% threshold.

7 May 2026, 07:31health.ec.europa.euEuropean Union

Global Scientific Review Links Chemicals And Climate Change To Fertility Declines

An April 2026 Nature review concludes that PFAS, microplastics, pesticides and other endocrine-disrupting chemicals, together with climate change, are measurably reducing fertility and fecundity across humans and wildlife. This cross-species evidence is likely to strengthen demands for class-based regulation of hazardous chemicals, shape the design of a global plastics treaty, and raise expectations for tighter reproductive-health and biodiversity protections over the coming decade.

7 May 2026, 05:45nature.comGlobal

ECHA Enters Follow-Up Stage on REACH Testing Proposal for 1,1'-[oxybis(ethyleneoxy)]diethylene

In late April 2026, ECHA moved its REACH testing proposal for 1,1'-[oxybis(ethyleneoxy)]diethylene into the follow-up phase, after the 27 April 2026 deadline for registrants to submit new 90-day repeated-dose and pre-natal developmental toxicity studies and update their dossiers. This shift means ECHA is now checking compliance with the 2023 testing decision and may involve national enforcement authorities where data are missing, increasing regulatory and enforcement risk for EU-based registrants using this substance.

5 May 2026, 07:24echa.europa.euEuropean Union

EU CLP ATP 22 Classifies Reaction Mass of 1,3-Dioxan-5-ol and 1,3-Dioxolan-4-ylmethanol as Reprotoxic 1B

EU CLP ATP 22 introduces a harmonised Reprotoxic 1B (H360Df) classification for the reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol in Annex VI, applying from 1 May 2026. This will require suppliers to update EU labels, safety data sheets and mixture classifications for products containing this substance in line with the new harmonised entry, as no substance-specific concentration limits have been set.

3 May 2026, 09:20eur-lex.europa.euEuropean Union

EU ECHA RAC Adopts Opinion on Harmonised Classification of 1-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-Hexamethyl-2-Naphthyl)ethan-1-one (CAS 1506-02-1)

By late April 2026, ECHA’s Committee for Risk Assessment had adopted and recorded a harmonised classification opinion under the EU CLP framework for 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one (CAS 1506-02-1), proposing Repr. 1B, STOT RE 2 and Aquatic Acute/Chronic 1 classifications. This severe hazard profile signals that a stricter EU legal classification may follow, so companies using this substance should monitor the forthcoming CLP Annex VI decision and prepare for potential impacts on labelling, safety data sheets and affected product lines.

3 May 2026, 09:20echa.europa.euEuropean Union

ECHA RAC Adopts Harmonised Classification Opinion for 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one (CAS 21145-77-7)

In April 2026 ECHA’s Risk Assessment Committee adopted a CLH opinion proposing harmonised CLP classification of 1-(5,6,7,8-hexamethyl-2-naphthyl)ethan-1-one as Repr. 1B, STOT RE 2, and Aquatic Acute/Chronic 1. If the Commission later confirms this in CLP Annex VI, manufacturers, importers and downstream users of this widely used fragrance ingredient will face tighter labelling duties, risk management and potential sector-specific restrictions across EU consumer and professional products.

3 May 2026, 09:19echa.europa.euEuropean Union

EU RAC Adopts Harmonised Classification Opinion for 1-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-Hexamethyl-2-Naphthyl)ethan-1-one

ECHA’s Committee for Risk Assessment has adopted a harmonised classification opinion for the fragrance substance 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one, proposing category 1B reproductive toxicity, STOT RE 2 and very high acute and chronic aquatic toxicity. If implemented in EU law, this would introduce a binding harmonised classification that tightens labelling, safety data sheets and risk management expectations for all EU manufacturers, importers and downstream users handling this substance.

3 May 2026, 09:19echa.europa.euEuropean Union

EU CLP: ECHA Reviewing CLH Proposal for Calcium 3,5-Dioxo-4-(1-Oxopropyl)-Cyclohexanecarboxylate (CAS 127277-53-6)

ECHA is reviewing a CLH proposal under the EU CLP Regulation to classify calcium 3,5-dioxo-4-(1-oxopropyl)-cyclohexanecarboxylate (EC 603-193-5; CAS 127277-53-6) as a skin sensitiser, suspected developmental toxicant and highly toxic to aquatic life, with the dossier currently in the RAC Opinion Development stage. If this classification is endorsed by RAC and implemented in CLP Annex VI, it would tighten labelling and risk management obligations for plant protection products containing this active substance in the EU and could affect product approvals, formulations and downstream agricultural uses.

3 May 2026, 09:19echa.europa.euEuropean Union

EU CLP ATP 22 Implements Reproductive Toxicity Classification for Reaction Mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol

ECHA’s CLH entry for reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol (EC 911-694-8) confirms a harmonised Repr. 1B (H360Df) reproductive toxicity classification implemented via CLP ATP 22 with application from 1 May 2026 in the EU. Companies using this reaction mass should treat this as a firm deadline to update CLP classification, labelling and safety data sheets and to reassess downstream regulatory and customer impacts ahead of the ATP’s application date.

3 May 2026, 09:18echa.europa.euEuropean UnionNetherlands

ECHA RAC Adopts CLH Opinion for Reaction Products of Ammonium Bromide and Sodium Hypochlorite (Generated In‑Situ)

In March 2026, ECHA’s Risk Assessment Committee adopted a CLH opinion proposing harmonised reproductive and aquatic hazard classification for reaction products of ammonium bromide and sodium hypochlorite (generated in-situ) in the EU. This opinion signals a likely future CLP Annex VI entry, with potential implications for labelling, risk management and biocidal authorisations once the European Commission adopts a corresponding ATP.

3 May 2026, 09:18echa.europa.euEuropean Union

ECHA Consultation on REACH Testing Proposals for N-cyclohexylbenzothiazole-2-sulfenamide (CAS 95-33-0)

ECHA is consulting on REACH testing proposals for N-cyclohexylbenzothiazole-2-sulfenamide (EC 202-411-2, CAS 95-33-0), covering bioaccumulation, repeated-dose oral toxicity, in vivo genetic toxicity and reproductive toxicity, with comments due by 12 June 2026. The outcome will determine whether new vertebrate studies are required for this substance and structurally related analogues, influencing future hazard data, classification decisions and REACH compliance planning.

3 May 2026, 07:34echa.europa.euEuropean Union

ECHA Publishes REACH Testing Proposal for Tall-Oil Pitch

ECHA has opened a REACH testing proposal consultation for Tall‑oil pitch (EC 232‑414‑4; CAS 8016‑81‑7), covering long-term aquatic, repeated-dose oral and reproductive/developmental toxicity endpoints with third-party data due by 12 June 2026. This signals intensified regulatory scrutiny of Tall‑oil pitch under REACH, so companies using or supplying it should quickly assess available study data, engage with the consultation, and anticipate possible future classification or risk-management actions.

3 May 2026, 07:32echa.europa.euEuropean Union

EU REACH Testing Proposal for N‑tert‑Butylbenzothiazole‑2‑Sulphenamide (CAS 95‑31‑8)

In April 2026, ECHA opened a REACH testing proposal consultation on N-tert-butylbenzothiazole-2-sulphenamide (CAS 95-31-8), seeking vertebrate studies on reproductive and developmental toxicity with comments due by 12 June 2026. Companies manufacturing, importing or using this substance should quickly review existing data and coordinate any submissions, as the outcome may drive new testing requirements and future risk management decisions under REACH.

3 May 2026, 07:32echa.europa.euEuropean Union

ECHA Invites Information on REACH Testing Proposal for N,N-bis(2-hydroxyethyl)dodecanamide

European Chemicals Agency has opened a REACH testing proposal consultation for N,N-bis(2-hydroxyethyl)dodecanamide, covering repeated-dose oral and reproductive/developmental toxicity endpoints with comments due by 12 June 2026. Companies registering, manufacturing, or using this substance should review existing data and consider submitting robust studies to avoid unnecessary vertebrate testing and anticipate potential impacts on hazard classification and risk management.

3 May 2026, 07:32echa.europa.euEuropean Union

ECHA Testing Proposal Consultation: Dodecyl Acrylate (EC 218-463-4, CAS 2156-97-0)

ECHA has opened a REACH testing proposal consultation for Dodecyl acrylate, seeking data on repeated-dose oral and developmental toxicity ahead of a 12 June 2026 deadline. Companies manufacturing, importing, or using this monomer in EU supply chains should review existing vertebrate and alternative data, consider submitting robust studies, and anticipate potential implications for future hazard classification and regulatory requirements.

3 May 2026, 07:31echa.europa.euEuropean Union