Chemicals | Monthly bulletin | April 2023

Eurofins newsflash Chemical

Europe

Condition of restriction for PFCA

On 25^th February 2023, the REACH restriction according to Annex XVII for Linear and branched perfluorocarboxylic acids (C9-C14 PFCAs), their salts and C9-C14 PFCA related substances, came into force.

Manufacturing, placing on the market and use of these substances, must now adhere to Entry 68 of Annex XVII of REACH legislation.

Some uses have been granted longer transition periods such as:

Textiles for oil- and water-repellency for the protection of workers from dangerous liquids that pose risks to their health and safety;
The manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:
- high performance, corrosion resistant gas filter membranes, water filter membranes and membranes for medical textiles;
- industrial waste heat exchanger equipment;
- industrial sealants capable of preventing leakage of volatile organic compounds and PM 2,5 particulates.

The transition period date shall end as of 4^th July 2023.

This restriction does not apply to articles placed on the market before 25 February 2023.

For more information, consult the ECHA’s website here.

Two new proposals for SVHCs candidate list

On 22nd February 2023, the European Chemical Agency (ECHA) published two proposals regarding substances to be considered to be identified as new substances of very high concern (SVHCs). If a substance is identified as an SVHC, it will be added to the Candidate List for eventual inclusion in the Authorisation List.

The substances are:

Substances	EC Number	CAS nuber	Applications
Bis(4-chlorophenyl) sulphone.	201-247-9	CAS 80-07-9	Used for the manufacture of chemicals, plastic products and rubber products.
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide.	278-355-8	75980-60-8	Used in inks and toners, coating products, photo-chemicals, polymers, adhesives, sealants, fillers, putties, plasters, and modelling clay

The deadline for comments on these submissions was 3^rd April 2023.

Additional recent updates regarding REACH Regulation

The following table provides a non-exhaustive summary of some recent updates regarding REACH Regulation (EC) No 1907/2006:

Summary of the most recent updates
Date	Subject	Link
21/02/2023	The new version of the ECHA’s Guidance on monomers and polymers has been published. The aim of this new version is to implement the BoA’s decision, it also includes changes to the description of registration obligations for those importing and manufacturing polymers and monomers.	More information on ECHA’S website here.
22/02/2023	New product categories for notifying poison centres With the improvements to the description of products and categories, the ECHA wants to help notifiers to specify more about the use and description of their hazardous mixtures.	More information on Poison Centres’s website here.
22/02/2023	Nanopinion: Graphene electronic tattoos	More information on EUON’s website here.
28/02/2023	ECHA updates recommendations to improve REACH registrations The updated recommendations will help companies to comply with REACH requirements and ensure the safe use of chemicals. They focus on avoiding animal testing, specifically providing advice on read across. Statistics on the progress made on evaluating registered substances in 2022 have also been released.	More information on ECHA’S website here.
06/03/2023	Commission Regulation (EU) 2023/464 of 3 March 2023 amending, for the purpose of its adaptation to technical progress, the Annex to Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals. It adds several new/updated methods to the list of approved methods for testing chemicals pursuant to REACH, which have the potential to reduce the amount of animal testing carried out using chemicals.	More information on European Commission here.
08/03/2023	The consolidated opinions of the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) and the supplementary opinion of RAC on the proposal to restrict lead in outdoor shooting and fishing submitted by ECHA was published.	More information on ECHA’S website here.
08/03/2023	Hexavalent chromium in electroplating Information about applications for authorisation of Cr(VI) in electroplating is available on the ECHA’s website.	More information on ECHA’S website here.
15/03/2023	ECHA published its regulatory strategy for flame retardants, identifying aromatic brominated flame retardants as candidates for an EU-wide restriction.	More information on ECHA’S website here.
15/03/2023	Publication of reports assessing the regulatory needs for a group of piperazine-functionalised polyamines	More information on ECHA’S website here.

Other interesting links about REACH from the ECHA’s website

Other interesting links about CLP on the ECHA’s website

European initiatives related to Chemicals

Recent initiatives by the European Commission related to Hazardous chemicals include:

Initiative	State
Prohibiting production for export of chemicals banned in the European Union. The aims to introduce a mechanism prohibiting production and/or export of certain hazardous chemicals that are banned in the EU – to protect non-EU countries from their negative effects on human health and the environment. The initiative will further align internal and external policies and improve the international standing of the EU, strengthening the credibility of its actions. It will fulfil a commitment made in the EU’s chemicals strategy for sustainability.	In preparation
Perfluoroctanoic acid (PFOA) This act concerns PFOA, its salts and PFOA-related compounds (included in Annex I of Regulation (EU) 2019/1021). It amends the PFOA concentration as an unintentional trace contaminant in substances, mixtures and articles, and removes a specific exemption that is no longer needed in the EU.	Commission adoption process
Update of EU rules for test methods This initiative will add a number of new/updated methods to the list of approved methods for testing chemicals pursuant to REACH, which have the potential to reduce the amount of animal testing carried out using chemicals.	Commission adoption process
Hazardous chemicals – rules on export and import (updated lists of chemicals) This initiative updates 2 lists of chemicals in the EU Regulation 649/2012 on international trade in hazardous chemicals: those subject to export restrictions (Annex I) those that cannot be exported (Annex V). It aims to prevent unwanted imports and ensure that information on hazards, risks and safe handling is always provided when hazardous chemicals are exported.	Feedback period open until 17^th April 2023

Chemicals legislations in the UK and Europe

Commom chemical legislation between the UK and the EU no longer exists post Brexit and as such, there are differences to be aware of in the regulatory environment in each of these markets. The expectation of a complete reformulation of the EU CLP before 2024 do that both regulations moves away to a more.

Below are some examples about differences that exist in chemical regulation in the EU and the UK.

An EU legal entity must be listed on both the SDS and the label. This means that a UK company selling a product in the EU will have to use a European legal entity to act as an intermediary, and vice versa.
Since January 2023 in Europe, SDSs must comply with Regulation (EU) 2020/878 throughout the European Union, which aligned the SDS format with the GHS Revised 8^th Edition. The UK has not yet implemented the latest update of the GHS into its legislation.
The UK SDS does not include the new warnings for nanoforms and endocrine disrupting chemicals or the new parameters in section 9.1 as indicated in the new revised version of the GHS and Regulation (EU) 2020/878.
In Europe, it is mandatory to use unique formula identification codes (UFI) and creating PCN files for mixtures. The unique formula identifier (UFI) code must to appear in section 1.1 of the SDS when exporting mixtures to the EU. Mixtures that meet specific conditions must also complete poison center notification (PCN).
In the UK it is not mandatory to generate or send a UFI code, but it is required for Northern Ireland, where the EU CLP Regulation applies and where there is a requirement to provide specific information about your products to the NPIS.

For more information about chemical legislation, consult the ECHA website for European legislation details and the HSE for UK legislation.

International

Regulatory proposals notified to WTO

The table below summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

Notification number	Countries	Title
G/TBT/N/CHE/275	Switzerland	Annex 1.10 of Chemical Risk Reduction Ordinance (ORRChem) 24 additional substances are included by reference to the EU regulations (Substances newly included in Annexes 1 -6 of Annex XVll of the EU-REACH regulation). These substances may no longer be supplied to the general public after December 1, 2023
G/TBT/N/CHE/276	Switzerland	Annexes 2 and 3 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance; ChemO) Annex 2: The technical regulations for the classification, labelling and packaging of substances and preparations will be updated and thus adapted to technical progress in the EU (19^th and 20^th ATP of the EU CLP Regulation): For two groups of substances (borates/ethylhexanoic acid and its salts), stricter criteria for classification with regard to reprotoxicity (additivity principle) are to be introduced. Annex 3: Ten substances are included in the candidate list of substances of very high concern. This listing triggers obligations along the supply chain.
G/TBT/N/EU/957	Europe	Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 as regards to harmonised classification and labelling of certain substances The purpose of this draft amendment of Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (the CLP Regulation) is to amend Table 3 of Part 3 of Annex VI to the CLP Regulation, by introducing new and revised entries for the harmonised classification and labelling of several substances or substance groups.

The New York Governor Signs Bill S01322 amending the law prohibiting the intentional use of PFAS substances in apparel

On March 24, 2023, Governor Hochul signed bill S01322 that amends the current law prohibiting the intentional use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in textiles.

For apparel, the bill S01322 aligns the terminology as well as the timeline of the New York PFAS in apparel law with that of the California law that prohibits intentional use of PFAS substances in textiles. However, the scope of the New York law is limited only to apparel, compared to much broader California law that covers textile products.

Following is a summary of the key amendments:

Requirements: prohibits intentional use of PFAS substances. In addition, one year after enactment of regulation implementing the law, but no later than January 1, 2027, the requirements will be revised to the PFAS level established by the Department of the Environmental Conservation (DEC).
Effective date: the effective date for general apparel is postponed by 1 year. Effective January 1, 2025, sale of new apparel containing intentionally added PFAS substances is prohibited.
Outdoor apparel for severe wet conditions:
- Definition added for outdoor apparel for severe wet conditions.
  "Outdoor apparel for severe wet conditions" means outdoor apparel that are extreme and extended use products designed for outdoor sports experts for applications that provide protection against extended exposure to extreme rain conditions or against extended immersion in water or wet conditions, such as from snow, in order to protect the health and safety of the user and that are not marketed for general consumer use.
- Effective January 1, 2028, sale of new outdoor apparel for severe wet conditions containing intentionally added PFAS is prohibited.

US EPA Amends Formaldehyde Standards for Composite Wood Products

On February 21^st, 2023, the US Environmental Protection Agency (EPA) issued a Final Rule (88 FR 10468) to amend the formaldehyde standards for composite wood products regulations under the Toxic Substances Control Act (TSCA). The Final Rule went into effect on March 23^rd, 2023.

The following changes has been made under the Final Rule:

Updated Incorporation-By-Reference (IBR) for certain voluntary consensus standards in 40 CFR 770.99 to reflect the most recent editions of those standards issued by the relevant standard organizations.
Conformed Voluntary Consensus Standards in Scope and Definitions
Increased flexibility for Third-Party Certifiers (TPC) by allowing TPCs to utilize external evaluations resources, such as contracting out inspections to a third party in order to complete the certification process in which TPCs certify that the products are TSCA Title VI compliant.
Addressed remote inspections to allow it when in-person, on-site inspections are temporarily impossible because of unsafe conditions caused by natural disasters, health crises, or political unrest.
Improved regulatory consistency through technical corrections

Sustainability, environmental and circular economy

Europe

European Commission publishes a proposal on ‘green claims’

On 22^nd March 2023, the European Commission put forward a proposal for a directive on substantiation and communication of explicit environmental claims, 'green claims directive', (COM/2023/166 final).

The proposal requires companies to substantiate claims relating to the impacts of their products and the activities of the organization on the environment using robust, science based and verifiable methods.

The directive would establish minimum requirements on the substantiation and communication of voluntary environmental claims and environmental labelling in business-to-consumer commercial practices, without prejudice to other EU legislation setting out conditions on environmental claims for certain products or sectors. It would also set up specific requirements for comparative claims.

More information can be found on the, European Commission‘s website here.

The annual statement relating to non-recycled plastic packaging waste

On 17^th March 2023, European Commission published Commission Implementing Regulation (EU) 2023/595 of 16 March 2023 establishing the form for the statement relating to the own resource based on non-recycled plastic packaging waste pursuant to Council Regulation (EU, Euratom) 2021/770.

This Regulation establishes the form for the statement relating to the own resource based on non-recycled plastic packaging waste. The annual statement shall serve as a supporting document for the Commission control and supervision of the own resource based on non-recycled plastic packaging waste.

This Regulation shall enter into force on 6^th April 2023.

France

Requirements for producers of packaging for the catering sector

On 8^th March 2023, the Minister for Ecological Transition and Territorial Cohesion published the Decree No. 2023-162 of March 7, 2023 relating to packaging waste and establishing the extended responsibility chain for producers of packaging used to market products consumed or used by professionals in the catering industry.

Legal persons who place packaged products consumed or used by catering professionals on the national market will be required to organise or contribute to the management of waste from the packaging of these products.

The decree specifies the field of application of this sector by defining the packaging as well as the producers targeted by these provisions. The decree defines the categories of packaging falling under this new EPR sector.

The provisions of the decree will go live the day after its publication.

AGEC Law measures that are in progress and to come

The "AGEC" law has considerably accelerated the change in the production and consumption model, by inviting producers to question the lifecycle of the products they produce and how they can be disposed of ultimately, and the environmental impact this may have.

Today, several measures are already playing an active part in our daily lives. Others are being deployed, with the same purpose. Below, is a summary of ten measures of the anti-waste law that are already at work:

Prohibition of several single-use plastic products, which pollute the environment.
End of disposable tableware in restaurants, especially fast food restaurants, for meals eaten on site.
Removal of plastic packaging around fruits and vegetables that can be sold in bulk.
Deployment of a new sorting information on the majority of everyday products to simplify sorting, give a second life to used products and improve recycling.
Generalisation of the collection of plastic packaging in the yellow bin.
A repairability index on electronic products, to better inform consumers and extend the life of products.
Obligations for manufacturers to put detailed information on the environmental characteristics of products online. For example, for textiles and the geographical traceability of the various stages of the manufacturing process.
Prohibition on disposing of non-food items that have not been sold.
The "repair bonus" for electrical and electronic devices
Implementation of in-store take-back of several everyday objects: furniture, toys, sports and leisure items, DIY and gardening items

Ten measures that will soon be implemented to continue the fight against all forms of waste in our daily lives:

Go beyond the repairability index by creating a new durability index for electronic products.
Cash receipts printed on demand for small daily purchases.
Creation of a new circular economy sector to better reuse and recycle packaging from the professional sector.
Go further on the collection of packaging, in particular plastic bottles, to aim for 90% collection for recycling in 2029 and develop the reuse of bottles.
Generalise packaging sorting bins in public spaces.
Implement the plastic packaging reduction, reuse and recycling (3R) strategy.
Transforming the textiles sector with the new 2023-2028 roadmap.
Develop plastic microfiber filter solutions on washing machines to avoid releases of microplastics that pollute the ocean.
Provide the French with a solution for collecting food scraps to convert this bio-waste into biogas or compost useful for the circular economy of the territories
Deploy eco-design bonuses and penalties to encourage manufacturers to make their products more sustainable and recyclable/ eco-friendly.

For more information, please visit the Ministry of Ecological Transition and Territorial Cohesion website here.

Publication of frequently asked questions related to environmental labelling

From 1^st January 2023, producers, importers and any marketers have must make information relating to the environmental qualities and characteristics of waste-generating products according to Decree in Council of State n°2022-748 and article 13 I of the Law of February 10, 2020 (AGEC), as they relate to the fight against waste and to contributing to the circular economy, to consumers.

Each product must have a corresponding "product sheet on environmental qualities and characteristics", available and easily accessible free of charge, for example using a search engine, on a dedicated page or website.

Environmental qualities and characteristics are to be disclosed include:

Compostability
incorporation of recycled material
reusability
recyclability
presence of precious metals and rare earths
presence of hazardous substances
geographical traceability
presence of plastic microfibres.

The French Ministry of Ecological Transition and Territorial Cohesion published a document with the aim of answering practical questions on the interpretation and implementation of the Decree in Council of State n°2022-748 of April 29, 2022. This document is available in French and English in its website here.

The New York Governor Signs Bill S01322 amending the law prohibiting the intentional use of PFAS substances in apparel

On March 24, 2023, Governor Hochul signed bill S01322 that amends the current law prohibiting the intentional use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in textiles.

Following is a summary of the key amendments:

Requirements: prohibits intentional use of PFAS substances. In addition, one year after enactment of regulation implementing the law, but no later than January 1, 2027, the requirements will be revised to the PFAS level established by the Department of the Environmental Conservation (DEC).
Effective date: the effective date for general apparel is postponed by 1 year. Effective January 1, 2025, sale of new apparel containing intentionally added PFAS substances is prohibited.
Outdoor apparel for severe wet conditions:
- Definition added for outdoor apparel for severe wet conditions.
  "Outdoor apparel for severe wet conditions" means outdoor apparel that are extreme and extended use products designed for outdoor sports experts for applications that provide protection against extended exposure to extreme rain conditions or against extended immersion in water or wet conditions, such as from snow, in order to protect the health and safety of the user and that are not marketed for general consumer use.
- Effective January 1, 2028, sale of new outdoor apparel for severe wet conditions containing intentionally added PFAS is prohibited.

International

New method of loss material determination in textiles during washing

In February 2023, the International Organization for Standardization (ISO) published the new method for systematically collecting material loss from fabrics under laundering test conditions to achieve comparable and accurate results. There is no direct correlation to material loss during domestic and commercial laundering. The method is designed to assess material loss of all types. The standard is:

Reference	title	Technical committe
ISO 4484-1:2023	Textiles and textile products — Microplastics from textile sources — Part 1: Determination of material loss from fabrics during washing	ISO/TC 38 Textiles