Medical Devices:
FDA’s SaMD Clinical Evaluation Guidance withdrawn
The FDA revised its guidelines in 2026 to ease the regulatory burden on wellness devices and CDS software that are considered low risk.
With the updates to the CDS Guidance , now it is more clear how the FDA determines whether a product is a CDS medical device or non-device CDS.
If the devices are non-invasive and have no diagnostic claims on their labels, they can enjoy a deregulation policy referred to as ‘enforcement discretion.’
Following the update on CDS Guidance, the guidance “Software as a Medical Device (SaMD): Clinical Evaluation” was withdrawn on January 7.
With this withdrawal many questions arise regarding the clinical validation of parameters like blood glucose.
The FDA advises that the best way to clear up any confusion on classification is through the proper submission process.
Source: https://www.fda.gov/media/109618/download
Cosmetics:
The EU Commission has restricted/banned 19 carcinogenic, mutagenic, or reprotoxic (CMR) substances in cosmetics
Cosmetics manufacturers are required to remove affected ingredients or reformulate products ahead of the application date, May 1, 2026.
15 substances will be added to the list of prohibited substances under Annex II (harmonized classification as CMRs under CLP Reg.)
The 15 substances added to the prohibited list under Annex II are:
- Multi-walled carbon tubes
- Reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol
- Acetone oxime
- (dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
- 2,3-epoxypropyl neodecanoate
- Benthiavalicarb-isopropyl
- 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
- 1,4-dichloro-2-nitrobenzene
- Fenpropidin
- n,n’-methylenediacrylamide
- tert-butyl 2-ethylperoxyhexanoate
- Trimethyl borate
- s-metolachlor
- Pyraclostrobin
Among other affected substances, Silver (massive and nano) is now banned, while micron-sized silver is restricted to specific colorant uses. Hexyl salicylate faces new concentration limits due to toxicity concerns.
These changes were published in the Official Journal on January 13 and will have significant implications for cosmetic product compliance.
CLP:
Proposed Labelling Requirements for Hazardous Substances in Batteries
The European Commission opened a consultation last month proposing the introduction of labelling on restricted and hazardous substances in the Batteries Regulation, according to the CLP Regulation.
The objective is to give harmonized obligations to companies to help them meet various labelling requirements for batteries placed on the EU market.
The new changes would comprise amendments to the 2023 Batteries Regulation, such as:
- Restricted substances contained in batteries, according to Annex I (other than mercury, lead, or cadmium), shall be labelled with their chemical name, according to CLP Article 18, when they fall below the applicable limit.
- Labelling of all hazardous substances in batteries with their name, also in line with CLP Article 18.
- Inclusion of electrochemical composition information on battery labels.
The Commission is expected to publish an update report in 2026 identifying substances of concern found in batteries or used during their manufacture.
Biocides:
ECHA has established a timeline for the formal authorization of four biocidal preservatives
Ranging from late 2026 to early 2027, the scheduled approval dates mark a critical deadline for chemical manufacturers to secure product authorization.
The biocidal preservatives requiring authorization are the following:
- BIT (1,2-benzisothiazol-3(2H)-one) | CAS 2634-33-5/EC 220-120-9, October 1, 2026. Approval for uses PT6 and PT13.
- Formic acid | CAS 64-18-6/EC 200-579-1, October 1, 2026. Approval of use PT6.
- DBNPA (2,2-dibromo-2-cyanoacetamide) | CAS 10222-01-2/EC 233-539-7, November 1, 2026. Approval for use PT6.
- MIT (2-methyl-2H-isothiazol-3-one) | CAS 2682-20-4/EC 220-239-6, February 1, 2027, Approval for use PT6.
Companies must finalize their compliance applications within these windows to ensure their goods remain legal for sale on the EU market.
Failure to meet these regulatory milestones will result in the mandatory removal of non-compliant products from European commerce.
Food:
EFSA has published an updated version of the guidelines for the submission of food additive authorization dossiers
This guidance goes into specific detail regarding scientific data needed for the approval of food additives. It discusses a step-by-step process in risk assessment, which involves identity, specifications, and exposure.
Tests include toxicology, genotoxicity, and environmental safety assessment.
The key changes include:
- Expanded data requirements, for both new authorizations and changes of existing ones.
- Greater focus on production processes and the characterization of the final additive
- A section dedicated to nanomaterials and small particles, to emphasize on exposure and risks assessment
- Updates in toxicology, with a clearer approach to genotoxicity testing, refined use of benchmark doses, and recognition of new methodologies (NAMs) and (Q)SAR models to support risk assessment.
Source: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2026.9778
