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Regulatory updates 01-2023

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Chemical


 

 

 

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.

 

The harmonised classification determining titanium dioxide as carcinogenic has been annulled

 

On 23rd November 2022, a judgment by the General Court was published which annuls the Commission Delegated Regulation of 2019 related to the harmonised classification of titanium dioxide. The finding of the Court is as follows:

 

  • The Commission made an error in its assessment of the reliability and acceptability of the study on which the classification was based.
  • The contested classification and associated labelling infringed the criteria according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer.
  • The contested classification and labelling are intended to identify and notify a carcinogenic hazard of titanium dioxide which, in the RAC Opinion, was classified as ‘non-intrinsic in a classical sense’.
  • The carcinogenicity hazard is linked solely to certain respirable titanium dioxide particles, when they are present in a certain form, physical state, size and quantity, it occurs only in lung overload conditions and corresponds to particle toxicity.

For more information, consult the press release nº 190/22 here.

 

Additional recent updates regarding REACH Regulation

 

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

 

Summary of the most recent updates

Date

Subject

Link

30/11/2022

Restriction of lead used in outdoor shooting and fishing

Publication of the final opinion related to proposed restriction of lead used in fishing and shooting by the Committee for Socio-Economic Analysis (SEAC).

More information on ECHA’S website here.

08/12/2022

Recommendation for safe and sustainable chemicals published

More information on European Commission website here.

12/12/2022

Publication of Study on (bio)degradation of, persistence of and safe by design nanomaterials.

More information on EUON’S website here.

13/12/2022

Publication of Draft Community Rolling Action Plan (CoRAP) update for years 2023-2025.

The draft CoRAP contains 24 substances, including 6 new substances compared to the current CoRAP 2022-2024; 5 substances are being planned for evaluation in 2023, and 19 are divided for evaluation in 2024 and 2025.

More information on ECHA’S website here.

14/12/2022

FPS Public Health Belgium has submitted a proposal to identify two chemicals of very high concern in the context of REACH.

The affected products go by the trade names Bisphenol S (BPS) and FC-770.

More information on FPS website here.

 

Other interesting links about REACH from the ECHA’s website

 

 

Additional recent updates regarding CLP Regulation

 

The following table provides a summary of some recent updates (non-exhaustive) regarding Regulation (EC) No 1272/2008 (CLP):

 

Summary of the most recent updates

Date

Subject

Link

19/12/2022

European Commission adopted the drat act related to Hazardous chemicals – updated rules on classification, labelling and packaging.

More information on European Commission here.

20/12/2022

The feedback period related to Revision of EU legislation on hazard classification, labelling and packaging of chemicals is opened until 24th February 2023.

More information on European Commission here.

 

Other interesting links about CLP from the ECHA’s website

 

 

Hexachlorobenzene under POP Recast Regulation

 

On 23rd November 2022, the European Commission published Commission Delegated Regulation (EU) 2022/2291 which amended Annex I to Regulation (EU) 2019/1021 on Persistent Organic Pollutants.

 

The below table summarises the relevant points:

 

Substance

Hexachlorobenzene (CAS nº 118-74-1)

Specific exemption on intermediate use or other specification

≤ 10 mg/kg (0.001%) in substances, mixtures or articles

Effective date

December 13, 2022 (20th day following its publication in the Official Journal of the EU)

 

Amendment to Annex IV and V on Persistent Organic Pollutants Regulation

 

On 12th November 2022, the European Commission published Regulation (EU) 2022/2400 of the European Parliament and of the Council of 23 November 2022 amending Annexes IV and V to Regulation (EU) 2019/1021 on Persistent Organic Pollutants.

 

The main points covered in the amendments are as follows:

 

  • The insertion of the Article 21a related to transitional provision of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) and dioxin-like polychlorinated biphenyl (dl-PCBs).
  • The addition of the following substance in the Annex IV to Regulation (EU) 2019/1021: Dicofol, Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I and Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds.
  • Replacement of the following rows in the Annex IV to Regulation (EU) 2019/1021:
    • Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)
    • Tetrabromodiphenyl ether C12H6Br4O, Pentabromodiphenyl ether C12H5Br5O, Hexabromodiphenyl ether C12H4Br6O, Heptabromodiphenyl ether C12H3Br7O and Decabromodiphenyl ether C12Br10O
    • Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF)
    • Hexabromocyclododecane
  • Several amendments to Part 2 of Annex V to Regulation (EU) 2019/1021.

On 22nd December 2022, the corrigendum to Regulation (EU) 2022/2400 was published.

 

UK

 

Possible extension to the REACH submission deadline

 

On 29th November 2022, the Department for Environmental, Food & Rural Affairs (Defra) published a summary of responses and government response related to consultations on extending current UK REACH submission deadlines.

 

After considering the responses, the UK government intends to introduce legislation that would facilitate the extension of submission deadlines across all tonnage bands by 3 years. This legislation is subject to the consent of the Scottish and Welsh governments.

 

For more information, please visit the GOV.UK website here.

 

Amendment to Persistent Organic Pollutants Regulation

 

On 6th December 2022, the Persistent Organic Pollutants (Amendment) (EU Exit) Regulations 2022 (S.I. 2022/1293) which amends Regulation (EU) 2019/1021 on persistent organic pollutants was published.

 

The main points covered in this amendment are as follows:

 

  • Addition of point 3 to the entry related to bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE) in Annex I, Part A which allows for the use of decaBDE in aircraft, motor vehicle and electric and electronic equipment.
  • Corrigendum to the entry related to perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X and perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X in Part A of Annex 1 to the EU Regulation which confer functions on EU entities which no longer have functions in the United Kingdom.

 

Miscellaneous

 

Miscellaneous technical publications relating to chemicals

 

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

 

Date

Country/ Region

Entity

Publication

18/10/2022

Ukraine

Verkhovna Rada

Resolution of October 18, 2022 ‘On Adoption as a Basis of the Draft Law of Ukraine on Chemical Safety and Management of Chemical Products’ (Reg. No. 8037).

The draft law on the management of chemicals has been adopted. The new law will become effective on November 2, 2024.

23/11/2022

Brazil

Ministry of Brazil

Bill PL 6120/2019 of the National Inventory of Chemical Substances with the aim of consolidating an information base on chemical substances produced or imported into Brazilian territory and related measures.

02/12/2022

Spain

Head of state

Law 25/2022, of December 1, on explosives precursors.

The sanctioning regime applicable in case of infringement of the provisions of Regulation (EU) 2019/1148, of the European Parliament and of the Council, of June 20, 2019, on the commercialisation and use of explosives precursors, is included.

20/12/2022

Europe

European Commission

Commission Implementing Decision (EU) 2022/2509 of 15 December 2022 determining quantitative limits and allocating quotas for substances controlled under Regulation (EC) No 1005/2009 of the European Parliament and of the Council on substances that deplete the ozone layer, for the period 1 January to 31 December 2023 (notified under document C(2022) 9109).

20/12/2022

Europe

European Commission

Commission Recommendation (EU) 2022/2510 of 8 December 2022 establishing a European assessment framework for ‘safe and sustainable by design’ chemicals and materials.

 

 

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Cosmetics & Personal Care


 

 

 

Recycled Plastic Packaging

 

It’s essential to find the packaging solutions that meet both technical and environmental requirements and expectations. In an era when sustainability is a major concern, plastic has earned a bad reputation.

 

However, plastic is lighter than glass and saves tons of CO2 emissions during product distribution, while offering a high level of protection to the cosmetic products they contain.

 

Most plastics are easily recyclable, so we should consider plastic waste a valuable raw material. Recycling plastic bottles and jars is an essential part of a circular economy.

 

Our highly skilled experts and our network of international accredited laboratories (DINCERTCO, ISO 17025, etc.) are on hand to ensure that your recycled plastic packaging does not compromise the safety, quality or efficacy of your products by providing a full range of tests:

 

  • Overall migration
  • Heavy metals
  • Release of metals
  • Release of carcinogenic primary aromatic amines
  • Release of substances of concern like Bisphenol A or Phthalates
  • Release of non-intentionally added substances
  • And more.

Learn more

 

 

 

High Tolerance Claim

 

The "Technical document on cosmetic claims", issued in 2017 by the European Commission's working group on cosmetic claims, along with the ARPP’s latest recommendations, in effect since July 1, 2019, and the recommendations of the ANSM and the DGCCRF, since April 2020, do not mention the "High Tolerance" claim and leave it up to each company to make its own interpretation, in line with common criteria.

 

However, it is generally accepted that a product aiming for "High Tolerance" is intended for the most intolerant, sensitive and pathologically inclined skin, requiring special attention.

 

Thus, we can say that a "High Tolerance" product has been formulated to minimise risks of allergic reactions or irritation, with a high level of safety guaranteed:

 

  • Impeccable acceptability data (use test under the control of a dermatologist, without clinical signs or major discomfort),
  • A good hindsight on the use of raw materials (cosmetovigilance data on products containing them),
  • Good knowledge of the raw materials used, i.e. well characterised.

The Regulatory Affairs Officer and Toxicologist Teams at Eurofins C&PC Regulatory & Toxicology can offer you personalised support for your claim assessment procedures, working closely with all relevant departments in the field of product safety to ensure optimal coordination.

 

Learn more

 

 

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Softlines & Leather


 

 

 

Europe

 

Best Available Techniques conclusion for textiles industry

 

On 20th December 2022, The European Commission published Commission Implementing Decision (EU) 2022/2508 of 9 December 2022 establishing Best Available Techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council on Industrial Emissions, for the textiles industry (notified under document C(2022) 8984).

 

The measures provided for in this Decision are in accordance with the opinion of the Committee established in Article 75(1) of Directive 2010/75/EU on industrial emissions (integrated pollution prevention and control).

 

These BAT conclusions do not cover the following:

 

  • Coating and lamination with an organic solvent consumption capacity of more than 150 kg per hour or more than 200 tonnes per year. These are covered by the BAT conclusions on surface treatment using organic solvents including preservation of wood and wood products with chemicals (STS).
  • Production of man-made fibres and yarns. This may be covered by BAT conclusions covering the sector of polymers production.
  • Unhairing of hides and skins. This may be covered by the BAT conclusions for the tanning of hides and skins (TAN).

 

EU Strategy for Sustainable and Circular Textiles

 

On 22nd November 2022, The European Commission published the opinion of the European Economic and Social Committee on communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the EU Strategy for Sustainable and Circular Textiles (COM(2022) 141 final).

 

The main points to consider are:

 

  • Competitivity aspects
  • Sustainability, circularity and transition to a green economy
  • Consumers and digitalisation
  • Education and working conditions
  • Funding and investments

The aim of the textile strategy is to facilitate a circular and digital transition with appropriate and flexible measures that address industry needs. Creativity and sustainable innovation must be an integral part of this strategy in order to develop a circular economy and minimise the environmental impact of the textile sector.

 

European Technical Specification for community face coverings

 

On 2nd November 2022, the European Committee for Standardisation published the following European Technical Specification:

 

CEN/TS 17553:2022 ‘Textiles and textile products - Community face coverings - Minimum requirements, methods of testing and use’.

 

This technical specification specifies the minimum requirements for reusable or single use community face coverings intended for the general public, which cover the nose, mouth and chin.

 

These requirements include: innocuousness, design (including fit), performance, test methods, marking, packaging, and usage information.

 

This document is not intended as guidance for medical face masks or personal protective equipment. This document excludes impermeable nose and mouth shields and face coverings incorporating inhalation and/or exhalation valves.

 

Standards updates

 

The following table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: the latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

(**) Date of availability: the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat.

 

CEN

Reference

Title

Date of withdrawal (*)

Supersedes

EN ISO 19410-1:2022

Footwear sizing – In shoe measurement - Part 1: Shoe length (ISO 19410-1:2022)

2023-05-31

 

Reference

Title

Date of Availability (**)

Supersedes

CEN/TS 17553:2022

Textiles and textile products - Community face coverings - Minimum requirements, methods of testing and use

2022-11-23

CWA 17553:2020

 

France

 

Roadmap for managing textile waste 2023-2028

 

On 28th September 2022, the Ministry of the Ecological Transition published the 2023-2028 roadmap for the management of textile waste. The main aims of the roadmap are:

 

  • To provide incentives for products that are designed to be more sustainable, more environmentally friendly, and remanufactured from recycled textiles;
  • Reduce the cost of repairing textiles so they last longer;
  • Develop new solutions for collecting used textiles, particularly in small towns and rural areas, to give them a second life;
  • Fund the sorting and repair of textiles to give them a second life;
  • Encourage the consistent recycling of non-reusable textiles in France to remanufacture textiles without depleting resources, through established processes.

 

The idea is that new specifications will be presented and implemented from 2023 for a period of six years, once the roadmap is approved.

 

Specifications for eco-organisations and individual systems in textile sector

 

On 25th November 2022, The Minister for Ecological Transition and Territorial Cohesion published Order of 23rd November 2022 laying down specifications for eco-organisations and individual systems in the extended sector of textile, footwear and household linen (TLC) production.

 

This order defines specifications for eco-organisations, and how they must contribute to or provide for the reuse, repair, recycling and treatment of waste from textiles, shoes and household linen (TLC) as mentioned in 11° of the article L.541-10-1 of the environment code. It also defines the specifications for the individual systems put in place, where applicable, by producers to individually fulfill their extended responsibilities and obligations.

 

The decree comes into force from January 1st, 2023.

 

US

 

Standards updates

 

See below a table summarising some recent ASTM standards updates:

 

Reference

Title

ASTM D3393-91 (2022)

Standard Specification for Coated Fabrics – Waterproofness - REAPPROVED

ASTM D4005-92 (2022)

Standard Test Method for Plastic-Coated Fabrics – Completeness of Fusion of PVC Dispersion Coatings - REAPPROVED

ASTM D5193/D5193M-93 (2022)

Standard Test Method for Coated Fabrics – Air Retention - REAPPROVED

 

 

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Toys, Childcare & Hardlines


 

 

 

Europe

 

Standards updates related to child care articles

 

The following table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: the latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

(**) Date of availability: date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat.

 

CEN

Reference

Title

Date of withdrawal (*)

Supersedes

EN 1888-2:2018+A1:2022

Childcare articles - Wheeled child conveyances - Part 2: Pushchairs for children above 15 kg up to 22 kg

023-06-30

EN 1888-2:2018/FprA1:2022
EN 1888-2:2018

Reference

Title

Date of availability (**)

Supersedes

CEN/TR 17842-1:2022

Playground equipment for children - Part 1: Replies to requests for interpretation of EN 1176:2017 and its parts (2018-2019)

2022-11-16

 

 

Miscellaneous technical publications relating to Toys

 

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

 

Date

Country/ Region

Entity

Publication

03/11/2022

Spain

BOE

(State official Publication)

Order PCM/1048/2022, of November 1, which modifies Annex II of Royal Decree 1205/2011, of August 26, on the safety of toys.

15/11/2022

France

DGCCRF

(Directorate General for Competition, Consumer Affairs and Fraud Prevention)

Stuffed animals: beware of the risk of ingestion by children

05/12/2022

Europe

European Commission

Consolidated text: Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance)Text with EEA relevance

12/12/2022

Germany

BfR

(German Federal Institute for Risk Assessment)

Gifts and fairy lights: Button cells can cause serious health damage to small children if swallowed

 

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

24/11/2022

EFSA (European food safety authority)

Protocol for the hazard assessment as part of the risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food

24/11/2022

EFSA (European food safety authority)

Phthalates and other plasticisers: Plan to guide EFSA assessment

This protocol marks the latest step in the preparatory work for re-evaluating the health risks from plasticisers used in different types of FCMs (e.g. plastics, rubber and inks) across the food chain (e.g. food processing equipment and packaging).

28/11/2022

European Commisision

Food contact materials: Thousands of illegal hazardous products intercepted and recalled in Europe

Report on the EU “Bamboo-zling” coordinated enforcement action on plastic food contact materials containing bamboo.

14/12/2022

EFSA (European food safety authority)

Risk assessment of food contact materials

 

Standard updates related to consumer products

 

The following table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: the latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

CEN

Reference

Title

Date of withdrawal (*)

Supersedes

EN 13451-11:2022


Swimming pool equipment - Part 11: Additional specific safety requirements and test methods for moveable pool floors and moveable bulkheads installed in pools for public use

2023-06-30

EN 13451-11:2014

EN 1335-1:2020+A1:2022

Office furniture - Office work chair - Part 1: Dimensions - Determination of dimensions

2023-05-31

EN 1335-1:2020/FprA1
EN 1335-1:2020

EN 1186-2:2022

Materials and articles in contact with foodstuffs - Plastics - Part 2: Test methods for overall migration in vegetable oils

2023-01-31

EN 1186-8:2002

EN 1186-6:2002

EN 1186-4:2002

EN 1186-2:2002

EN 1186-12:2002

EN 1186-10:2002

EN 1186-3:2022

Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration in evaporable simulants

2023-02-28

EN 1186-9:2002

EN 1186-7:2002

EN 1186-5:2002

EN 1186-3:2002

EN 1186-15:2002

EN 1186-14:2002

EN 927-2:2022

Paints and varnishes - Coating materials and coating systems for exterior wood - Part 2: Performance specification

2023-05-31

EN 927-2:2014

EN 13300:2022

Paints and varnishes - Paints and varnishes for interior walls and ceilings - Classification

2023-05-31

EN 13300:2001/AC:2002

EN 13300:2001

EN ISO 4628-5:2022

Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 5: Assessment of degree of flaking (ISO 4628-5:2022)

2023-05-31

EN ISO 4628-5:2016

EN ISO 1522:2022

Paints and varnishes - Pendulum damping test (ISO 1522:2022)

2023-05-31

EN ISO 1522:2006

EN ISO 7784-3:2022

Paints and varnishes - Determination of resistance to abrasion - Part 3: Method with abrasive-paper covered wheel and linearly reciprocating test specimen (ISO 7784-3:2022)

2023-05-31

EN ISO 7784-3:2016

 

France

 

Launch of big information campaign relating to Info-tri

 

In December 2022, the Ministry of Ecological Transition and Territorial Cohesion launched an information campaign related to Info-tri, with the cooperation of Ademe and several eco-organisations, to inform and publicise new signage which allows consumer products used every day to be sorted better. This campaign began in December 2022 for a period of two months thought the internet, television and partnerships with web content creators, helping to raise awareness among young people.

 

On other hand, the Ministry of Ecological Transition and Territorial Cohesion published the update document:

 

FAQ relating to TRIMAN signage and information specifying the terms and conditions sorting

 

For more information, consult the official publication from the Ministry of Ecological Transition and Territorial Cohesion here.

 

Definition of products for which sale in bulk is prohibited

 

On 22nd November 2022, the French Ministères économiques et financiers communicated submitted a Decree to the European Commission which adopts the list of products for which sale in bulk is prohibited for public health reasons (2022/818/F).

 

This Decree identifies the products for which sale in bulk is prohibited by the legislation in force and those for which sale in bulk is prohibited under EU law, in particular on hygiene grounds, but also where use of such products may pose a risk to consumers.

 

If sale in bulk is not expressly prohibited for certain products, but doubts remain and conditions for their sale appear unsatisfactory, in particular on safety grounds, the Decree provides the option to regulate these by means of an Order.

 

UK

 

Overall recycling aim for packaging in 2023

 

On 23rd November 2022, the Statutory Instruments 2022 No. 1222 The Producer Responsibility Obligations (Packaging Waste) (Amendment) (England and Wales) Regulations 2022 was published.

 

This Regulation set an overall recycling target as well as material-specific recycling targets for 2023 on obligated producers in England and Wales in relation to glass, plastic, aluminium, steel, paper/board and wood.

 

This Regulation amends the Producer Responsibility Obligations (Packaging Waste) Regulations 2007 (S.I. 2007/871). It came into force on 1st January 2023.

 

US

 

CPSC Updates Infant Walker Safety Standard

 

On November 29th, 2022, the U.S. Consumer Product Safety Commission (CPSC) issued a direct final rule (16 CFR 1216) to update the mandatory Safety Standard for Infant Walkers. The final rule incorporates the latest version of ASTM F977-22e1, Standard Consumer Safety Specification for Infant Walkers, without any modifications.

 

ASTM F977-22e1 includes editorial revisions to the previous version of the standard, ASTM F977-22.

 

The direct final rule will become effective on February 25th, 2023 unless the CPSC receives significant or adverse comments by December 29th, 2022.

 

Ukraine

 

Chemical requirements for teats and soothers

 

On 24th September 2022, the Order No. 1734/2022 related to the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers was approved and on 14th October 2022 was registered in the Ukraine’s Justice Ministry with the number 1241/38577.

 

The main points of this Order are:

 

  • General requirements related to safety indicating the limits:
    • N-nitrosamines: ≤ 0.01 mg/kg
    • N-Nitrosatable substances: ≤ 0.1 mg/kg

and general basic information to determine the release of N-nitrosamines and N-nitrosatable substances.

 

  • Indication of the criteria and method to determine the release of N-nitrosamines and N-nitrosatable substances in teats and soothers.

From 1st January 2024, it will be forbidden to sell and use teats and shooters of rubber and elastomers which do not comply with this Order.

 

The effective date of this order is 28th April 2023.

 

Triclosan ban in manufacture of food contact plastics

 

On 24th September 2022, the Order No. 1735/2022 concerning food contact materials was approved and on 11th October 2022 was registered in the Ukraine’s Justice Ministry with the number 11222/38558.

 

The main takeaway is the prohibition of the following in the manufacture of plastic materials and articles intended to come into contact with food:

 

  • 2,4,4’-trichloro-2’-hydroxydiphenyl ether(CAS No. 0003380-34-5) (Triclosan)

Plastic materials and articles manufactured with Triclosan that are placed on market before 1st January 2023 may continue to be marketed until 1st January 2024.

 

The effective date of this order is 21st January 2023.

 

New legislation on food contact materials and articles

 

On 3rd November 2022, Law No. 2718-IX on food contact materials was adopted.

 

This law defines the legal and organisational principles to guarantee the safety of materials and objects intended to be in contact with food products, in order to guarantee the protection of human health, as well as other rights and interests of consumers.

 

This law contains similarities with European legislation, such as Regulation (EC) 1935/2004, Regulation (EC) 2023/2006 and Regulation (EC) 450/2009.

 

The effective date of this order is 19th November 2025.

 

Israel

 

Regulatory proposals notified to the WTO for toys and childcare

 

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

 

Notification number

Countries

Category

Title

G/TBT/N/ISR/1196/Add.1

Israel

Toys

SI 562 part 3 -Safety of toys: Migration of certain chemical elements.

The revision of the Mandatory Standard SI 562 Part 3 was published in the Israel Official Gazette Section of Government Notice no. 10401 on 17 November 2022 and entered into force immediately, allowing a transition period until 16 April 2023. During this time, products may be tested according to the old or new standard editions.

G/TBT/N/ISR/1212/Add.1

Israel

Childcare

SI 6558 part 1 - Jewellery safety: Children's jewellery - Safety requirements

The revision of the Mandatory Standard SI 6558 Part 1 was published in the Israel Official Gazette Section of Government Notice no. 10395 on 13 November 2022 and entered into force immediately, allowing a transition period until 13 February 2023. During this time, products may be tested according to the old or the new standard editions.

 

 

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PPE


 

 

 

Europe

 

Changes to product safety standards

 

On 7th October 2022, the European Commission published Decision 2022/1914 which amends the Implementing Decision (EU) 2020/668 as it relates to harmonised standards for personal flotation devices – buoyancy aids, lifejackets and accessories.

 

This table summarises the rows which have been added to the Annexes to Implementing Decision (EU) 2020/668:

 

Added standards in Annex I

Row

Reference

Title

39

EN ISO 12402-5:2020

Personal flotation devices – Part 5: Buoyancy aids (level 50) - Safety requirements (ISO 12402-5:2020)

40

EN ISO 12402-6:2020

Personal flotation devices – Part 6: Special purpose lifejackets and buoyancy aids - Safety requirements and additional test methods (ISO 12402-6:2020)

41

EN ISO 12402-8:2020

Personal flotation devices – Part 8: Accessories – Safety requirements and test methods (ISO 12402-8:2020)’.

Added standards in Annex II

Row

Reference

Title

30

EN ISO 12402-5:2006

Personal flotation devices – Part 5: Buoyancy aids (level 50) - Safety requirements (ISO 12402-5:2006)

31

EN ISO 12402-6:2006

Personal flotation devices – Part 6: Special purpose lifejackets and buoyancy aids - Safety requirements and additional test methods (ISO 12402-6:2006)

32

EN ISO 12402-8:2006

Personal flotation devices – Part 8: Accessories – Safety requirements and test methods (ISO 12402-8:2006)

Note: Date of withdrawal of these Standards is the 7th October 2022.

Added standards in Annex IIII

Row

Reference

Title

4

EN ISO 12402-2:2020

Personal flotation devices – Part 2: Lifejackets, performance level 275 – Safety requirements (ISO 12402-2:2020)

5

EN ISO 12402-3:2020

Personal flotation devices – Part 3: Lifejackets, performance level 150 – Safety requirements (ISO 12402-3:2020)

6

EN ISO 12402-4:2020

Personal flotation devices – Part 4: Lifejackets, performance level 100 – Safety requirements (ISO 12402-4:2020)

Notice:

Application of clause 5.6 of this standard does not confer a presumption of conformity with the basic health and safety requirement set out in point 1.1.1. of Annex II to Regulation (EU) 2016/425.

Application of clauses 5.1.2, 5.1.3, 5.1.5, 5.1.7, 5.2, 5.3.1.1, 5.3.1.2, 5.3.2.2, 5.3.2.3, 5.3.4.3, 5.3.4.4, 5.6.1.4, 5.6.1.7, 5.6.1.8, 5.6.1.9, 5.6.1.10 and 5.6.1.11 to this standard does not confer a presumption of conformity with the basic health and safety requirement set out in point 1.2.1. of Annex II to Regulation (EU) 2016/425.

Application of clauses 5.1.2, 5.2, 5.3.1.1, 5.3.2.2, 5.3.4.2, 5.3.4.4, 5.6.3 and 5.7 to this standard does not confer a presumption of conformity with the basic health and safety requirement as set out in point 3.4 of Annex II to Regulation (EU) 2016/425.

 

Standards updates

 

The following table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: the latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

CEN

Reference

Title

Date of withdrawal (*)

Supersedes

EN ISO 10819:2013/A2:2022

Mechanical vibration and shock - Hand-arm vibration - Measurement and evaluation of the vibration transmissibility of gloves at the palm of the hand - Amendment 2 (ISO 10819:2013/Amd 2:2021)

2023-04-30

 

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