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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Chemicals | Monthly bulletin | February 2023

Chemicals | Monthly bulletin | February 2023

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Europe

 

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

 

On 17th January 2023, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs.

With the addition of 9 new substances, the current list of SVHCs now contains 233 substances.

 

See below a table indicating the latest substances addition:

 

 

Substance name

EC number

CAS number

Reason for inclusion

Examples of use(s)

1

1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]

253-692-3

37853-59-1

Very persistent and very bioaccumulative 
(REACH Article 57 e)

While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution. 

2

2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol

201-236-9

79-94-7

Carcinogenic 
(Article 57 a)

As a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.

3

4,4'-sulphonyldiphenol
(Bisphenol S)

201-250-5

80-09-1

Toxic for reproduction (Article 57 c); Endocrine disrupting properties (Article 57 f – environment); Endocrine disrupting properties 
(Article 57 f – human health)

In the manufacture of: pulp, paper and paper products, textile, leather or fur and chemicals.
 

4

Barium diboron tetraoxide

237-222-4

13701-59-2

Toxic for reproduction
(Article 57 c)

In paints and coatings.

5

Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof

-

-

Very persistent and very bioaccumulative (Article 57 e)

As a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.

6

Isobutyl 4-hydroxybenzoate

224-208-8

4247-02-3

Endocrine disrupting properties 
(Article 57 f – human health)

In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modelling clay and inks and toners.
 

7

Melamine

203-615-4

108-78-1

Equivalent level of concern having probable serious effects to human health (Article 57 f – human health); 
Equivalent level of concern having probable serious effects to the environment (Article 57 f – environment)

In polymers and resins, coating products, adhesives and sealants, leather treatment products, laboratory chemicals.

8

Perfluoroheptanoic acid and its salts

-

-

Toxic for reproduction 
(Article 57 c); Persistent, bioaccumulative and toxic (Article 57 d); 
Very persistent and very bioaccumulative (Article 57 e); Equivalent level of concern having probable serious effects to human health (Article 57 f – human health);
Equivalent level of concern having probable serious effects to the environment (Article 57 f – environment)

While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution.

9

reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine

473-390-7

-

Very persistent and very bioaccumulative (Article 57 e)

Used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.

 

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.

 

European assessment framework for chemicals and materials

 

On 8th December 2022, the European commission published Commission Recommendation of 8.12.2022, establishing a European assessment framework for ‘safe and sustainable by design’ chemicals and materials.

 

The European Commission has adopted a recommendation and its annex to promote research and innovation for safer and more sustainable chemicals and materials.

 

This text encourages innovation to replace hazardous substances in products and processes, for example in materials in contact with foodstuffs, such as plastic packaging or food containers, textiles or technology products, and information and communication products, such as laptops and tablets. It aims to develop new chemicals and materials, to optimize or redesign production processes and the use of substances currently on the market in order to improve their safety and sustainability.

 

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

29/11/2022

Request to the European Chemicals Agency (ECHA) to support the Commission’s preparation of a restriction proposal for the use and presence of hazardous chemicals in childcare articles based on Article 68(2) of REACH.

More information on ECHA’S website here.

21/12/2022

Germany submitted a proposal to the European Chemicals Agency (ECHA) that would restrict the sale of mixtures and articles containing BPA at a concentration greater than 10 ppm (0.001 % by weight), as well as other bisphenols and bisphenol derivatives (BoSC – BPB, BPS, BPF and BPAF) thought to have endocrine disrupting properties.

More information on ECHA’S website here.

21/12/2022

The European Chemicals Legislation Finder (EUCLEF) has been updated with information on the:

 

  • Cosmetics Regulation;
  • Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive;
  • Plant Protection Products Regulation; and
  • Pesticides Residues Regulation.

More information on ECHA’S website here.

21/12/2022

Nanopinion:

Controlling exposure to nanomaterials.

More information on EUON’S website here.

06/01/2023

Request to the European Chemicals Agency (ECHA) to reassess the concentration limits for eight Polycyclic Aromatic Hydrocarbons (PAHs) in loose rubber granules and mulches used in children’s playgroungds, as well as other domestic applications, and propose restrictions if necessary.

More information on ECHA’S website here.

13/01/2023

ECHA receives PFASs restriction proposal from five national authorities.

Denmark, Germany, the Netherlands, Norway and Sweden have submitted a proposal to ECHA to restrict per- and polyfluoroalkyl substances (PFASs) under REACH.

The proposal became available on ECHA’s website on 7th February 2023.

More information on ECHA’S website here.

 

Other interesting links about REACH from the ECHA’s website

 

 

Other interesting links about CLP from the ECHA’s website

 

 

European Initiatives related to chemicals, POP and RoHS legislation

 

Recent initiatives by the European Commission related to chemicals, POP and RoHS legislations include:

 

Initiative

State

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.

Feedback period closed in January 2023; adoption by Commission is planned for Q1 2023.

Persistent organic pollutants – PFOS limits and exemptions

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 EU since it is no longer needed.

The European Commission is preparing the draft act.

Revision of EU legislation on hazard classification, labelling and packaging of chemicals

For the implementation of the Green Deal, the chemicals strategy for sustainability sets out a number of actions that require a targeted revision of the Regulation on the classification, labelling and packaging of chemical substances and mixtures. Various options for revision will be analysed in an impact assessment and, based on the results, the Commission will present legislative proposals for a revision of both the enacting terms of and the annexes to that Regulation.

The feedback period concerning adoption by the Commission is opened until 29th March 2023.

 

 

Miscellaneous technical publications relating to PFASs

 

The latest publications in relation to PFASs are summarised in the table below:

 

Date

Country/ Region

Entity

Publication

13/01/2023

BfR

(German Federal Institute for Risk Assessment)

Germany

Per- and polyfluoroalkyl substances (PFASs): Proposal for restriction under the REACH Regulation submitted to the European Chemicals Agency.

13/01/2023

The Environmental Protection Agency

Denmark

Proposal for limiting PFAS submitted to the EU.

13/01/2023

Federal Institute for Occupational Safety and Health (BAUA)

Germany

Restriction proposal for PFAS submitted to the European Chemicals Agency.

13/01/2023

National Institute for Public health and the Environment

Netherlands

Proposed European PFAS ban officially submitted.

13/01/2023

Norwegian Environment Agency

Norway

Proposals to ban PFAS have been submitted to ECHA.

The Norwegian Environment Agency and the authorities in four other countries have submitted a proposal to the European Chemicals Agency to ban fluorinated substances (PFAS).

13/01/2023

Swedish Chemicals Agency

Sweden

Sweden behind a bill to stop the use of PFAS within the EU.

Together with authorities in four other countries, the Chemicals Inspectorate has submitted a comprehensive proposal to the EU to limit the use of roughly 10,000 PFAS chemicals.

17/01/2023

Ministry of Ecological Transition and Territorial Cohesion

France

The 2023-2027 "PFAS" action plan.

The aim is to strengthen the protection of French people and the environment against the risks associated with PFAS.

This plan is based on following six areas of action:

 

  • Stablishing standards to guide public action;
  • Introducing a broad ban at European level to eliminate the risks associated with the use or the placing on the market of PFAS;
  • Improving knowledge of discharges, as well as the impregnation of environments to reduce the exposure of populations;
  • Significantly reducing industrial emissions;
  • Ensuring complete transparency on the information available;
  • Integrating actions on PFAS into the micropollutants plan.

 

US

 

New York Approves PFAS in Textiles Regulation

 

The State of New York recently approved Bill A07063A to amend Section 37-0121 of the Environmental Conservation Law to prohibit intentionally added PFAS chemicals in apparel products, effective December 31st, 2023.

 

PFAS is defined as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.

 

Apparel is defined as clothing items intended for regular wear or formal occasions, including, but not limited to, undergarments, shirts, pants, skirts, dresses, overalls, bodysuits, vests, dancewear, suits, saris, scarves, tops, leggings, leisurewear, formal wear, onesies, bibs, and diapers. Apparel does not include professional uniforms or outerwear intended for extreme conditions.

 

New York Prohibits PFAS in Carpets and Establishes New Carpet Recycling Program

 

The State of New York recently approved Bill A09279A to amend Article 27 of the Environmental Conservation Law by adding a new title 33 to require producers to submit a plan for the establishment of a carpet collection program for unused and discarded carpets for the Department of Environmental Conservation’s (DEC) approval by December 31st, 2023. No later than July 1st, 2024 or six months after the plan is approved by the DEC, whichever occurs later, producers must implement the carpet collection program utilizing collection sites, and producers may not sell carpets in the state unless the producer is registered with the DEC on and after the date of implementation of the carpet collection program. On or before July 1st, 2025, and annually thereafter, producers must submit a report to the DEC that includes, for the previous program year, a description of the program. Beginning July 1st, 2024, retailers may not sell carpets in the state unless the producer of such carpet is participating in a carpet collection program. On or after one year after a plan is approved by the DEC, carpets sold in the state must be accompanied by the following identifying information:

 

  • Name of the producer and contact information; and
  • Carpet material, composition, and type of construction.

All carpets sold in the state must be manufactured with the following minimum amounts from post-consumer sources:

 

  • Within 1 year after the plan is approved by the DEC, a minimum of 10% post-consumer content;
  • Within 4 years thereafter, a minimum of 20% post-consumer content; and
  • 5 years thereafter, a minimum of 30% post-consumer content.

The new bill will also prohibit carpets containing PFAS substances for any purpose, effective December 31st, 2024.

 

A carpet is defined as a manufactured article that is (a) used in commercial buildings or single or multifamily residential buildings, (b) affixed or placed on the floor or building walking surface as a decorative or functional building interior or exterior feature, and (c) primarily constructed of a top surface of synthetic or natural face fibers or yarns or tufts attached to a backing system made of synthetic or natural material. A carpet does not include handmade rugs, area rugs, or mats.

 

PFAS substances are defined as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.

 

California Designates Nail Products Containing Toluene as a Priority Product

 

California’s Department of Toxic Substances Control (DTSC) listed a new Priority Product under the Safer Consumer Products Regulations: nail products containing toluene. The covered products include nail products containing toluene, including nail coatings and nail polish thinners that contain toluene as an added ingredient, contaminant, or residual. Nail coating includes any clear or colored paint, polish, lacquer, enamel, or gel product marketed or sold for application to fingernails or toenails.

 

By March 2nd, 2023, domestic and foreign manufacturers of the covered products must submit to the DTSC a Priority Product Notification (PPN), naming all of the manufacturer’s products that contain toluene, either as an intentionally added ingredient or as a contaminant. After submitting the PPN, manufacturers will have the option to submit one of the following by June 30th, 2023:

 

  • an Alternatives Analysis Threshold Notification;
  • a Chemical Removal Intent/Confirmation Notification;
  • a Product Removal Intent/Confirmation Notification;
  • a Product-Chemical Replacement Intent/Confirmation Notification; or
  • a Preliminary Alternatives Analysis Report or other alternate reporting options.

The Alternatives Analysis Threshold (AAT) for toluene in nail products is set at 100 parts per million (ppm). Manufacturers that demonstrate and certify that the concentration of toluene in their priority product does not exceed the ATT of 100 ppm will not be required to submit an Alternative Analysis Report.

 

For more information on the PPN, please visit the DTSC’s website here. To see the full text of the new Regulation, please click here.

 

New York Regulates Mercury in Cosmetics and Personal Care Products

 

The State of New York recently approved Bill S8291A to amend Section 37-0117 of the Environmental Conservation Law to prohibit Mercury in cosmetics and personal care products, effective June 1st, 2023. Mercury is defined as elemental mercury Hg, mercuric iodide, mercury oxide, mercurous chloride, ethyl mercury, phenyl mercuric salts, ammoniated mercury, amide chloride of mercury, mercury sulfide or cinnabaris, or mercury iodide. 

 

A cosmetic product is defined as any article (a) intended to be rubbed, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for beautifying, promoting attractiveness, or altering the appearance, and (b) intended for use as a component of any such article.A personal care product is defined as any product intended for cleaning or cleansing any part of the body, such as the skin and hair, and including but not limited to, hair shampoo, hair conditioner, soap, bath gels and other bath products.

 

US Passes Modernization of Cosmetics Regulations Act

 

On December 29th, 2023, President Biden approved the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulations Act (MCRA). The MCRA amends Chapter VI of the Food, Drug, and Cosmetic Act (FDCA) and significantly expands the Food & Drug Administration’s (FDA) authority over cosmetics. Below are some highlights of the MCRA:

 

  • Facility Registration:
    • Existing cosmetic product manufacturing facilities must register with the FDA by December 29th, 2023. New facilities must register within 60 days of first engaging in manufacturing or by February 27th, 2024, whichever date is later. Facility registrations must be renewed every two years thereafter.
  • Product listing:
    • Responsible persons must submit product listings for currently marketed cosmetic products to the FDA by December 29th, 2023. For new cosmetic products, product listings must be submitted within 120 days after marketing such product. Updates to product listings must be submitted every year thereafter.
    • Product listings must include:
      • Facility registration number of each facility
      • Name and contact number of the responsible person
      • Product’s name
      • Applicable cosmetic category or categories
      • List of ingredients, including any fragrances, flavors, or colors, with each ingredient identified by name
  • Updated labeling Requirements:
    • Domestic address, phone number, or electronic contact information, through with the responsible person can receive adverse event reports
    • Identification of fragrance allergens
    • Updated labeling requirements for cosmetic products intended for professional use
  • Mandatory recall and facility suspension authority:
    • FDA granted the authority to request a voluntary recall or issue a mandatory recall if it determines that there is reasonable probability that a product is adulterated or misbranded and the use of or exposure to the product will cause serious adverse health consequences or death
    • FDA granted authority to suspend a facility registration if it determines that there is reasonable probability of causing serious adverse health consequences or death
  • Talc-containing cosmetics:
    • Requires FDA to propose regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products by December 29th, 2023
  • PFAS in cosmetics:
    • Requires Secretary of Health and Human Services to assess the use of PFAS substances in cosmetic products, including risks associated with such use

 

China

 

China Releases List of New Pollutants for Priority Management

 

On December 30th, 2022, the China’s Ministry of Ecology and Environment issued Order No. 28 to release the first official list of new pollutants for priority management, which will become effective on March 1st, 2023. The list of new pollutants for priority management contains the following 14 types of new pollutants and its environmental risk control measures:

 

  • Perfluorooctane sulfonic acid, its salts and perfluorooctane sulfonyl fluoride (PFOS and it’s salts)
  • Perfluorooctanoic acid, its salts and related compounds (PFOA related)
  • Decabromodiphenyl ether
  • Short-chain chlorinated paraffins
  • Hexachlorobutadiene
  • Pentachlorophenol and its salts and esters
  • Dicofol
  • Perfluorohexyl sulfonic acid, its salts and its related compounds (PFHxS Related)
  • Declone and its cis and trans isomers
  • Dichloromethane
  • Trichloromethane
  • Nonylphenol
  • Antibiotic
  • Obsolete class
    • Hexabromocyclododecane
    • Chlordane
    • Mirex
    • Hexachlorobenzene
    • DDT
    • α- hexachlorocyclohexane
    • β- hexachlorocyclohexane
    • Lindane
    • Endosulfan prodrug and its related isomers
    • Polychlorinated biphenyls

Thailand

 

Thailand Issues New Standard for Food Utensils Coated with Fluropolymer

 

The Thai Industrial Standards Institute (TISI) has recently released a new and updated industry product standard. Please see Table 1 below:

 

Table 1:

 

Category

Standard

Effective Date

Food Contact Materials

TIS 2622-2556 Fluropolymer-Coated Utensils for Food

April 2nd, 2024

 

International

 

Miscellaneous technical publications relating to food contact materials

 

The latest publications in relation to food contact materials are summarised in the table below:

 

Date

Entity

Publication

17/11/2022

MERCOSUR

Publication of MERCOSUR/GMC/ Res. No 26/22 which modifies the Resolution no. 40/15 “MERCOSUR technical regulation on cellulosic materials, packaging and equipment intended to be in contact with food”.

MERCOSUR Members (Argentina, Brazil, Paraguay and Uruguay) have to transpose the amendment into their national law by May 16, 2023.

05/01/2023

Brazilian Health Regulatory Agency (ANVISA)

Draft resolution number 1134, 23 December 2022.

This Draft Resolution proposes the modification of the current.

regulatory framework regarding the technical regulation on provisions for packaging, coatings, utensils, lids and metallic equipment in contact with food. (G/TBT/N/BRA/1464).

 

Sustainability, environmental and circular economy

 

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

 

Date

Country/ Region

Publication

16/12/2022

Belgium

An international instrument to reduce plastic pollution.

From November 26 to December 2, the 1st meeting of the Intergovernmental Negotiating Committee on Plastic Pollution (INC1) took place in Punta del Este, Uruguay. This is the 1st session of a series of 5 whose objective is to set a new legally binding international instrument to fight against plastic pollution, including in the seas and oceans. The final result of these negotiations is expected by the end of 2024. It should have an impact comparable to that of the Paris Climate Agreements.

16/12/2022

France

Order of December 8, 2022 establishing the national plan for reducing emissions of atmospheric pollutants.

The PREPA defines the actions to be implemented to achieve the national objectives for reducing emissions of certain atmospheric pollutants (SO2, NOx, VOCNM, NH3, PM2.5) for the years 2025 and 2030 defined in article D. 222- 38 of the environment code pursuant to article L. 222-9 of the environment code.

22/12/2022

Europe

Commission Delegated Regulation (EU) 2022/2526 of 23 September 2022 amending Regulation (EU) 2017/852 of the European Parliament and of the Council as regards the temporary storage of mercury waste in liquid form (C/2022/6696) was published.

31/01/2023

Europe

New product priorities for Ecodesign for Sustainable Products.

European Commission opened the public consultation which the Commission seeks views on the categories of new products that is subject to performance and information-related requirements, to ensure greater sustainability.

14/01/2023

UK

The UK Environment Secretary announced that a range of polluting single-use plastics will be banned in England in October 2023. The ban will include single-use plastic plates, trays, bowls, cutlery, balloon sticks, and certain types of polystyrene cups and food containers. For more information here.

14/01/2023

UK

Publication of the Summary of responses and government response related to a call evidence on single-use plastic items which are commonly littered. They were interested in views on following single-use plastic items: wet wipes, tobacco filters, sachets, single-use cups.

They were also asking for views on how to shift away from single-use items to reusable or refillable alternatives.

17/01/2023

UK

The Packaging Waste (Data Reporting) (Scotland) Regulations 2023 (Scottish S.I. 2023 No.7).

These Regulations impose requirements on producers who are established in Scotland to collect data on the packaging they supply to others, and, in some cases, to report some of that information to the Scottish Environment Protection Agency (SEPA).