Chemicals | Monthly bulletin | June 2023

Eurofins newsflash Chemical

Europe

New update to Candidate List of Substances of Very High Concern (SVHCs)

On 14^th June 2023, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of 2 new substances, the current list of SVHCs now contains 235 substances.

See below a table indicating the latest substances addition:

Nº	Substance name	EC number	CAS number	Reason for inclusion	Examples of use(s)
1	Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide	278-355-8	75980-60-8	Toxic for reproduction (Article 57c)	Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modelling clay.
2	Bis(4-chlorophenyl) sulphone	201-247-9	80-07-9	vPvB (Article 57 e)	Manufacture of chemicals, plastic products and rubber products.

Legal obligations for companies using SVHC substances include:

Suppliers provide customers and consumers with enough information to allow for safe use of products that contain a substance of very high concern (SVHC) above a concentration of 0.1 % (weight by weight)
Importers and producers of these products must notify the ECHA if their article contains SVHC substances above a concentration of 0.1% weight by weight (w/w) and the substance is present in those products in quantities totalling over 1 tonne per producer or per importer per year. The notifications have to be submitted within six months from the date it that the substance is included in the list.
Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet.
Under the Waste Framework Directive (Directive 2008/98/EC on waste- WFD), any supplier of an article containing a substance of very high concern (SVHC) in a concentration above 0.1% weight by weight (w/w) on the EU market is required to submit a SCIP Notification on that article to ECHA, as of 5 January 2021. SCIP is the database holding information on Substances of Concern in articles, as such or in complex objects (products), established under the WFD. The SCIP database complements the existing notification obligations for Candidate List substances in articles subject to REACH regulation and its related communication through the supply chain, according to Articles 7 (2) and 33 respectively.

Click here to access the official List from ECHA’s website.

PFOA amendment in POP European Regulation

On 28^th April 2023, the European Commission published an amendment to the Regulation (EU) 2019/1021 on persistant organic pollutants (POP). The amendment is related to perfluorooctanoic acid (PFOA), its salts, and PFOA-related compounds.

The Commission Delegated Regulation (EU) 2023/866 of 24 February 2023 indicates the following several amendments in Annex I, Part A, the fourth column of the table, and entry ‘Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds’:

In point 3, the date of review and assessment by the Commission has been changed to, 25 August 2023, related to exemptions from control measures of a substance present as an unintentional trace contaminant.
Point 4 has been replaced by the following text:

‘4. For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFOA and its salts equal to or below 1 mg/kg (0,0001 % by weight) where they are present in polytetrafluoroethylene (PTFE) micropowders produced by ionising irradiation or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders until 18 August 2023. All emissions of PFOA during the manufacture and use of PTFE micropowders shall be avoided and, if not possible, reduced as far as possible. The limit of 1 mg/kg (0,0001 % by weight) shall apply only to manufacture, placing on the market and use of PFOA and its salts where they are present in PTFE micropowders that are transported or treated for the purpose to reduce the concentration of PFOA and its salts below the limit of 0,025 mg/kg (0,0000025 % by weight).’;

In point 5, subpoint (e) has been deleted which allowed the manufacturing use of PFOA, its salts and related compounds for manufacturing 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 the leakage of volatile organic compounds and PM2.5 particulates;

until 4 July 2023.

This Regulation entered into force on 18^th May 2023 and shall apply from 18 August 2023.

For more information, consult the official publication in European Commission website here.

New restriction for lead in PVC articles

On 8^th May 2023, the European Commission published an amendment to the restriction list in Annex XVII of Regulation (EC) No 1907/2006, as regards lead and its compounds in PVC (polymers or copolymers of vinyl chloride).

The Commission Regulation (EU) 2023/923 of 3^rd May 2023 adds six points to entry 63 – lead and its compound, column 2, of Annex XVII of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

Lead is a toxic substance which has a negative impact on human health and the environment. It is used to make PVC thermally stable during compounding and article production. It also protects PVC against photo-degradation. To comply with the proposed restriction, it is necessary to restrict all lead in PVC, regardless of its intended function. As a means of limiting the carryover of lead in new products, through recycling processes, economic operators should be granted a 24-month period to adapt to the new requirements for flexible PVC; for rigid PVC, the obligation will apply 36 months regulation enters into force.

The main new restrictions are:

Items shall not be placed on the market, if the concentration of lead is equal to or greater than 0.1 % of the weight of the PVC material. This shall come into effect on 29 November 2024. Exceptions:
- PVC articles containing recovered flexible PVC until 28 May 2025;
- PVC articles containing recovered rigid PVC until 28 May 2033, if the concentration of lead is lower than 1.5 % of the weight of the recovered rigid PVC;
- From 28 May 2026, rigid PVC recovered for construction items referenced in this entry shall only be used for the production of new such construction items.

Suppliers of PVC items containing recovered rigid PVC shall submit documentary evidence to national enforcement authorities upon request, substantiating claims about the recovered origin of the PVC in those items. Certificates issued by schemes to provide proof of traceability and recycled content, such as those developed according to EN 15343:2007 or equivalent recognised standards, may be used to substantiate such claims for PVC items produced in the European Union. Claims made as to the recovered origin of the PVC in imported articles shall be accompanied by a certificate that provides equivalent proof of traceability and recycled content, issued by an independent third party.

This amendment shall not apply to:

PVC-silica separators in lead acid batteries, until 28 May 2033;
Jewellery items and items supplied to the general public, with accessible parts, with a concentration of lead equal to or greater than 0.05 % by weight which can be placed in the mouth by children;
Items within the scope of:

- Regulation (EC) No 1935/2004 - food contact materials and articles which are intended to come into contact with food
- Directive 2011/65/EU - Restriction of the use of certain hazardous substances in electrical and electronic equipment
- Directive 94/62/EC - packaging and packaging waste
- Directive 2009/48/EC - safety of toys

PVC articles placed on the market before 28^th November 2024.

This Regulation shall enter into force on 28^th May 2023.

For more information, consult the official publication in European Commission website here.

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
22/05/2023	New IUCLID version including formatting updates This version is the first to include formatting changes since the release schedule was adapted to deliver this type of change in the first half of the year. The release was originally scheduled for April, but to ensure the quality of the release, it was delayed by one month.	More information on ECHA’s website here.
20/04/2023	ECHA provides advice on new hazard classes for substances and mixtures: Endocrine disruptors (ED) for human health or the environment; Persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); and Persistent, mobile and toxic (PMT); very persistent and very mobile (vPvM).	More information on ECHA’s website here.
03/05/2023	Publication of the first batch of questions and answers focuses on the info session on the PFAS restriction proposal.	More information on ECHA’s website here.

Other interesting links about REACH from the ECHA’s website

Recent updates regarding CLP

The table below outlines a summary of the most recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:

Summary of the Most Recent Updates

Date

Subject

Link

22/05/2023

Relevant changes for PCN notification

These changes include:

Update of the European product categorisation system (EuPCS) categories
Removal of unused fields in the product record
Update of the field path for the market placement
Introduction of new validation rules.
Every document included in the dossier must provide information in the following fields “documentType”, “creationDate”, and “lastModificationDate”

For more information, consult Poison centres‘ website here.

Other interesting links about CLP on the ECHA’s website

European published initiatives

May 2023, The European Commission adopted the following published initiatives:

Electrical equipment – Mercury in melt pressure transducers for specific capillary rheometers (RoHS exemption).
This initiative concerns a request for an exemption for mercury in melt pressure transducers for capillary rheometers under extreme conditions used as monitoring and control instruments.

Chemicals classification and labelling – Assignment of notes to certain substances.
This initiative assigns new notes (added to the CLP Regulation in a recent amendment) to certain substances; in this case, the modification of entries in Part 3 of Annex VI for 2-ethylhexanoic acid and its salts, boric acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate, and disodium tetraborate pentahydrate.

Revision of Regulation (EC) 648/2004 on detergents

On 28^th April 2023, the European Commission proposed a revised regulation on detergents, with the aim of improving the current rules to better protect health and the environment. This proposal covers new innovative products like detergents containing micro-organisms, sustainable new practices, like the refill sale of detergents, digital labelling, and a product passport for detergents and surfactants.

The main points are:

Simplify market rules, such as the obligation to provide an ingredient data sheet for hazardous detergents among other things;
Labels will also be simplified;
Introduce voluntary digital labelling;
Facilitate the sale of innovative, safe products;
Increase sustainability and safety through clear rules for refilled detergents;
The introduction of a product passport will strengthen market surveillance and ensure that only safe detergents complying with the rules enter the Single Market.

Following the ordinary legislative procedure, the European Parliament and Council must now approve this proposal.

For more information, consult the European Commission website here.

Germany

Answers to frequently asked questions related to BPA

On 21^st April 2023, the German Federal Institute for Risk Assessment (BfR) published a compilation of common questions and answers about bisphenol A (BPA).

BPA plays an important role in the production of polymers and plastics, and is used in a variety of sectors and applications. It can be found in a wide range of everyday consumer goods.

Due to its properties as an endocrine disruptor, it has been classified as toxic to reproduction (category 1B). This substance can cause adverse health effects by affecting the endocrine system.

Bisphenol A has been identified as a Substance of Very High Concern (SVHC) under European chemical legislation. The use of some bisphenols has been or is being restricted in the EU to protect human health and the environment.

California Adds 2 New Chemicals to Proposition 65 List

Effective April 21, 2023, California’s Office of Environmental Health Hazard Assessment (OEHHA) added 1,1,1-trichloroethane (CAS Registry Number 71-55-6) and leucomalachite green (CAS Registry Number 129-73-7) to the Proposition 65 list of chemicals known to cause cancer. The warning requirement for significant exposures to these chemicals will take effect on April 21, 2024.

For more information, consult Chemicals Listed Effective April 21, 2023 as Known to the State of California to Cause Cancer: 1,1,1-Trichloroethane and Leucomalachite Green - OEHHA.

International

New ban on use of substances in Persistent Organic Pollutants

On 15^th May 2023, the annual meetings between the Conferences of the Parties to the Basel, Rotterdam and Stockholm Conventions took place. In this meeting, the elimination of the use of the following persistent organic pollutions which have been added to the Annex A of the Stockholm Convention, was decided upon:

Methoxychlor (pesticide for insects)
Dechlorane Plus (flame retardant)
UV-328 (UV absorbent)

The Stockholm Convention on Persistent Organic Pollutants is a global treaty to protect human health and the environment from chemicals that remain in the environment for long periods, disperse widely geographically, accumulate in the fatty tissue of humans and wildlife, and/or have a harmful impacts on human health and/or the environment.

For more information, consult the BRS convention ‘s website here.

Sustainability, environmental and circular economy

Europe

One step closer for ecodesign requirements for consumer products

On 22 May 2023, the European Council adopted its position on ecodesign requirements for sustainable products.

The Council position clarifies how member state experts and industry should be involved in the future development of ecodesign requirements and the criteria and aspects that should be considered before ecodesign requirements are developed.

The new ecodesign regulation will be applicable to almost all categories of products and establish harmonised requirements for specific product groups, such as recycled content, presence of substances that inhibit circularity, etc... The aim is to make products more durable, reliable, reusable, upgradable, reparable, recyclable, easier to maintain, and more energy- and resource-efficient.

The proposal will also establish a "Digital Product Passport" which will provide information about a products' environmental sustainability, including its carbon and environmental footprints, durability, reusability, upgradability, reparability, etc. Other interesting points in this new proposal are provisions on transparency, the prevention of destruction of unsold consumer products, and green public procurement.

The new regulation will replace the current Ecodesign Directive 2009/125/EC, enlarging the scope to cover almost all kinds of goods placed on the EU market, only exempting food, feed, medicine and veterinary products and motor vehicles.

As regards textiles, the proposal introduces a ban on the destruction of textiles, footwear and apparel, with a four-year exemption for medium-sized companies, and a general exemption for small and micro companies.

Now the next step will be negotiations between the European Parliament and the Council, which will begin when the Parliament adopts its position.

For more information, consult the official publication here.

Miscellaneous technical publications relating to environmental, plastics, packaging and waste

The table below summarises the most recent publications regarding the environment, circular economy and sustainability (non-exhaustive):

Entity	Date	Publication
French Ministry of Ecological Transition and Territorial Cohesion	27/04/2023	End of disposable tableware in fast food restaurants: brands have made a good start in bringing their restaurants into compliance, controls will be strengthened to monitor compliance with their action plans On January 1, 2023, France became the first country in Europe to ban disposable tableware for on-site catering. This progress report validates the working method adopted by the ministers.
European Commission	28/04/2023	Mercury-added products – EU ban on export, import and manufacture This European-published initiative will align EU legislation with the Minamata Convention on Mercury and help phase out the use of mercury in these products worldwide, thus offering further protection for the environment and human health.
European Commission	02/05/2023	Single-use plastic beverage bottles – EU rules for calculating, verifying and reporting on recycled plastic content This European-published initiative will give legal clarity to Member States so they can properly implement EU rules on single-use plastics. This will help increase the use of recycled material in the EU economy and reduce plastic waste incineration and landfill.
BfR ( German Federal Institute of Risk Assessment)	08/05/2023	Many people concerned about microplastics In a poll about certain health and consumer topics, microplastics came in at the top of the list of concerns. In second place, antibiotic resistance is mentioned, and in third place residues of pesticides in food. Microplastics are also a topic of natural and social science research at the BfR.
European Commission	12/05/2023	Environmental Liability Directive (evaluation) This European-published initiative will assess whether the directive is fit for purpose and any shortcomings it may have. It will also reflect on calls from the European Parliament and the European Court of Auditors to strengthen its application.
European Commission	15/05/2023	Circular economy – monitoring framework (revision) This European-published initiative aims to better cover the production stage of the economic cycle and the links between circularity, climate neutrality and zero pollution, in line with the European Green Deal.
ANSES (French Agency for Food, Environmental and Occupational Health & Safety)	17/05/2023	ANSES calls for the adoption of a more protective definition for nanomaterials ANSES recommends improving the current definition of nanomaterials by providing a broader definition, not only based on dimensional criteria, and regardless of the sector in which nanomaterials are used. The hazards posed by nanomaterials should be one of points to take into account when expanding the definition.