Consumer Products | Monthly bulletin | May 2023
Chemical | Cosmetics & Personal Care | Softlines & Leather | Toys, Childcare & Hardlines
New version of test method for nickel release
On 22nd February 2023, the definitive text of a new version EN 1811 was approved by CEN/CENELEC for publication and was distributed by the Central Secretariat.
This standard specifies the test method for the release of nickel from all types of articles intended to come into direct and prolonged contact with the skin, and this way to determine whether such articles are in compliance with the Entry No 27 in Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH).
Eyeglass frames and sunglasses are excluded from the scope of this standard because they are subject to the requirements of EN 16128.
The main changes of the new version EN 1811:2023 are as follows:
- The unit for nickel release is expressed as in the REACH regulation (“µg·cm-2·week-1”)
- Update of terms and definitions, such as: homogeneous, surface finish and disassemble
- Permittable of use of ready solutions in reagents added
- Notes regarding the adhesion of wax to cover cracks and fissures.
- Information on number of test samples added
- The following points have been clarified:
- Definition of sample area
- Handling of small samples and filtering of release solution in the release procedure.
- Filtering of release solutions and blank solutions
- Test report updated:
- The minimum information required in test reports for each determination
- The following information is to be included in the test report if requested:
- Sample area used for calculation (cm²) and the information on the areas that have been excluded
- Volume of test solution used
- Limit of quantification (LOQ)
- Annex B, requirements for quality control material deleted
- Annex B, for preparation of samples revised
- Table B.1, general procedure for post assemblies and inhomogeneous articles added
- Figure B.9, flowchart for sample preparation and testing procedure for complete watches added
- Bibliography updated
The date of withdrawal has been set as 31st August 2023, which means that national standards conflicting with this new version have to be withdrawn by this date. However, the standard is expected to be harmonised under EU REACH Regulation (EC) No 1907/2006 once it is accepted by the European Commission.
Eight recommended substances for REACH Authorisation List
On 12th April 2023, ECHA published its eleventh recommendation for the REACH Authorisation List. In this publication, the ECHA recommends that, the European Commission, adds the following eight substances to the Authorisation List. The European Commission will decide which substances are to be included in the Authorisation List and which conditions apply to each substance.
# |
Substance name |
EC No |
Examples of uses in the scope of authorisation |
SVHC-relevant intrinsic property |
1 |
Ethylenediamine |
203-468-6 |
Use as processing agent in refinery streams, corrosion inhibitors, process additives, use in control of odour emissions |
Respiratory sensitiser (Article 57(f) –human health) |
2 |
2-(4-tert-butylbenzyl) propionaldehyde and its individual stereoisomers |
- |
Fragrance in washing and cleaning products, air care products, polishes and waxes |
Toxic for Reproduction |
3 |
Lead |
231-100-4 |
Batteries, ammunition, cables, vehicles, machinery, electronics, radiation shielding, sanitary, construction, art and musical instruments |
Toxic for Reproduction |
4 |
Glutaral |
203-856-5 |
Leather tanning, X-ray film development, corrosion inhibitor, crosslinker and auxiliary for polymerisation reactions |
Respiratory sensitiser (Article 57(f) –human health) |
5 |
2-methyl-1-(4-methyl thiophenyl)-2-morpho linopropan-1-one |
400-600-6 |
Photoinitiator in UV-curable coatings, inks and adhesives |
Toxic for Reproduction |
6 |
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone |
404-360-3 |
Photoinitiator in UV-curable coatings, inks and adhesives |
Toxic for Reproduction |
7 |
Diisohexyl phthalate |
276-090-2 |
No registered uses |
Toxic for Reproduction |
8 |
Orthoboric acid, sodium salt |
237-560-2 |
No registered uses |
Toxic for Reproduction |
Once these substances have been added to the REACH Authorisation List with the aim to protect workers and the environment, companies will need to apply for authorisation to continue using them.
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 |
21/03/2023 |
Community rolling action plan update covering the years 2023, 2024 and 2025 Lists 24 substances suspected of posing a risk to human health or the environment, for evaluation by 12 Member State Competent Authorities, under the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48). |
More information on ECHA’s website here. |
24/03/2023 |
A pilot project for restricted perfluorocarboxylic acids (PFCAs) Inspections as part of this pilot project will begin in 2023 and continue in 12 participating countries throughout 2024. The objective is to protect consumers from being exposed to PFCAs and related substances, including perfluorooctanoic acid (PFOA), which have been identified as substances of very high concern due to their hazardous properties. |
More information on ECHA’s website here. |
28/03/2023 |
Evaluating results from 55 extended one-generation reproductive toxicity studies under REACH. Publication of final report of the EOGRTS review project. |
More information on ECHA’s website here. |
Other interesting links about REACH from the ECHA’s website
- Registry of restriction intentions until outcome - ECHA (europa.eu)
- Registry of SVHC intentions until outcome - ECHA (europa.eu)
- Substance evaluation - CoRAP - ECHA (europa.eu)
- Adopted opinions and previous consultations on applications for authorisation - ECHA (europa.eu)
- Applications for authorisation - current consultations - ECHA (europa.eu)
- Current calls for comments and evidence - ECHA (europa.eu)
- Authorisation List - ECHA (europa.eu)
- ECHA's completed activities on restriction
- Submitted restrictions under consideration
- Assessment of regulatory needs list
Classification of substances and mixtures with endocrine disruption properties
On 31st March 2023, the European Commission published an amendment related to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures with endocrine disrupting properties.
These substances and mixtures with endocrine disrupting properties pose a concern to public health and the environment. It has been proven that endocrine disruption can lead to certain disorders in humans, among others birth defects; developmental, reproductive or neurodevelopmental disorders; cancer; diabetes; and obesity. These disorders have a high and increasing incidence in both children, adults and animals.
This situation creates the need to establish a legal hazard identification, with classes of danger, indications of danger, pictograms and category codes, and amendment of annexes I, II, III and VI of Regulation (EC) No 1272/2008 related to the substances and mixtures with these types of properties.
It amends the following annexes to Regulation (EC) No 1272/2008, which relate to Endocrine disruption:
- Annex I – Classification and labelling requirements for hazardous substances and mixtures
- Annex II - Special rules for labelling and packaging of certain substances and mixtures
- Annex III - List of hazard statements, supplemental hazard information and supplemental label elements
- Annex VI - Harmonized classification and labelling for certain hazardous substances
For more information, consult the European Commission publication here.
Other interesting links about CLP on the ECHA’s website
- Registry of CLH intentions until outcome - ECHA (europa.eu)
- Harmonised classification and labelling consultations - ECHA (europa.eu)
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 |
United Kingdom |
The Great Britain (GB) mandatory classification and labelling list (the GB MCL list). For the purposes of transparency, the United Kingdom is signposting Members to the GB mandatory classification and labelling list, which is a list of all the mandatory classification and labelling requirements of substances and groups of substances made by the Secretary of St ate in accordance with Article 37 and Article 37A of the retained CLP Regulation (EC) No. 1272/2008 as amended for Great Britain. |
|
United Kingdom |
Proposed Great Britain (GB) mandatory classification and labelling of 98 hazardous chemical substances The purpose of this proposal is to amend the GB mandatory classification and labelling list (the GB MCL list), following review, by introducing new and revised entries for the mandatory classification and labelling of 97 hazardous chemical substances and removing one substance from the GB MCL list. |
|
Europe |
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures This proposal shall add new provisions to simplify labelling, by adapting the regulation to new market trends, such as online sales and digital labelling, by introducing classification rules for multi-constituent substances and by referring to new hazard classes, as well as streamlining some procedures. |
Packaging check to transport of dangerous goods by land and sea
On 23rd and 24th March 2023, the French authorities published the following orders related to packaging intended for the transport of dangerous goods by land and sea:
- Decree of 15 March 2023 approving the Technical Verification Office (BVT) for the inspection of packaging, large bulk containers and large packaging intended for the transportation of dangerous goods by land and sea.
- Decree of March 15, 2023 approving FORM-EDIT - CeFEA Division for the control of packaging, large bulk containers and large packaging intended for the transportation of dangerous goods by land and sea.
- Decree of March 15, 2023 approving the Metal Packaging Study and Research Laboratory (LEREM) for the inspection of packaging intended for the transportation of dangerous goods by land and sea.
- Decree of 15 March 2023 approving the National Metrology and Testing Laboratory (LNE) for the inspection of packaging intended for the transportation of dangerous goods by land and sea.
Approval of the standard models of packaging intended for the transportation of dangerous goods and the control of the mass production of packaging in accordance with the standard models is carried out by inspection bodies approved by the Minister responsible for industrial safety. This is also the case for the periodic tests and inspections of intermediate bulk containers, and for the preliminary and periodic inspections of the industrial establishments authorised to carry out these tests and inspections themselves. These decrees authorise different entities to carry out these checks, inspections and tests.
These decrees came into force on April 1, 2023.
ISO 8124-3:2020/Amd.1:2023 New impact for migration of Heavy metal
On 23rd March 2023, the International Organization for Standardization (ISO) Technical Committee: ISO/TC 181 issued a new amendment ISO 8124-3:2020/Amd.1:2023 for toy safety standards regarding heavy metal. The amendment will come into effect as long as the standard issued.
The main points of the new amendment are as follows:
- Add new definition of Slime: Water-based gel or gel-like material, clear or coloured, which is viscous, slippery, and often non-Newtonian fluids, intended for play by hand manipulation, kneading and stretching.
- Combine the putty definition into modelling clay as "Modelling Clay and Putty": Flexible solid or semi-solid mixtures that retain their shape and form when moulded into a shape, intended to create representations of objects by hand manipulation or to be extruded into profiles by the toy.
- Add element Boron (B) migration limit for Slime and Modelling Clay and Putty:
Slime: 1250 mg/kg
Modelling Clay and Putty: 3750 mg/kg
- Adjust specific element migration limit for Slime and Modelling Clay and Putty:
Slime: The migration limits for all eight elements align with those of finger paint
Modelling clay and Putty: The element Barium (Ba) migration limit is 350 mg/kg
Below are the new limits laid out by the amendment:
New limit of ISO 8124-3:2020/Amd.1:2023
Toys material |
Element Limit(mg/kg) |
||||||||
Antimony (Sb) |
Arsenic (As) |
Barium (Ba) |
Cadmium (Cd) |
Chromium (Cr) |
Lead (Pb) |
Mercury (Hg) |
Selenium (Se) |
Boron (B) |
|
Any toy material given in Clause 1,except modelling clay and putty, finger paint, and slime |
60 |
25 |
1000 |
75 |
60 |
90 |
60 |
500 |
-- |
Finger paint |
10 |
10 |
350 |
15 |
25 |
25 |
10 |
50 |
-- |
Slime |
10 |
10 |
350 |
15 |
25 |
25 |
10 |
50 |
1250 |
Modelling clay and putty |
60 |
25 |
350 |
50 |
25 |
90 |
25 |
500 |
3750 |
Sustainability, environmental and circular economy
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 |
Direction générale de la concurrence, de la consommation et de la répression des fraudes (DGCCRF) |
December 2022 |
Methodological note from the SCL – Analysis of nanoparticles and characterization of nanomaterials present in consumer products. |
Organisation for Economic Co-operation and Development (OECD) |
March 2023 |
WORKSHOP REPORT ON FLEXIBLE FOOD-GRADE PLASTIC PACKAGING Economic, Regulatory or Technical Barriers to Sustainable Design from a Chemicals Perspective – How Can Policy Makers Help? |
The European Consumer Organization (BEUC) |
March 2023 |
'Carbon neutral', 'CO2 neutral' or 'climate neutral', and other such types of eco-friendly claims, have sprouted on supermarket shelves in recent years. But they are scientifically inaccurate and can mislead consumers. BEUC (European Consumers' Organization) has collected some examples of these claims in 10 European countries in a recently published report. The report demonstrates their proliferation in the food sector and how these claims harm consumers. |
The European Consumer Organization (BEUC) |
March 2023 |
Promising EU plans to tackle greenwashing and promote repair |
The European Consumer Organization (BEUC) |
March 2023 |
REVISION OF THE PRODUCT LIABILITY DIRECTIVE Time to ensure effective and comprehensive protection for consumers damaged by defective products. |
Cosmetics & Personal Care
Identifying PFAS in your cosmetic and packaging products
Per- and Polyfluorinated Alkyl Substances (PFAS) are a large group of manufactured compounds that are used in a wide range of industrial and consumer applications, including cosmetic products. PFAS are often added deliberately as ingredients in some cosmetic products to help condition and smooth the skin, making it appear shiny, or to alter product consistency and texture, etc. In addition, they might be present as unintended degradation products or impurities resulting from the production of PFAS precursors used in certain cosmetic products. Some of them are considered toxic and could be absorbed by and accumulate in the human body for a long time, acting as so-called ‘forever chemicals’ with adverse health effects.
Many countries are leading the way in eliminating PFAS from cosmetic and packaging products. PFAS methodologies and regulations are continually evolving as additional compounds are identified, and local regulations continue to expand their testing requirements for these contaminants. With our dedicated teams, Eurofins network of laboratories is able to offer you the flexibility to develop a testing plan and adapt to the continually changing analytical needs. With more than 20 years of experience, we are able to test a wide range of matrices for up to 75 PFAS compounds, with a breadth of equipment dedicated to PFAS analysis and LOQ/LOD capabilities.
New ex vivo model mimicking atopic dermatitis
Atopic dermatitis (AD) is a chronic cutaneous inflammatory disorder, characterised by skin barrier disruption. Our teams of experts have developed a new ex vivo biological model that mimics atopic dermatitis.
This model uses a mix of five cytokines to induce an atopic dermatitis phenotype, which is then characterised by transcriptomic analysis to detect new markers, analysis of the barrier function by Raman spectroscopy, labelling and immunolabeling.
This model will allow us to contribute to the i-DEMO CANNACOS project with Greentech, Garoma and CBM which aims to study the skin penetration of different cannabinoids and screen molecules of several phyto-cannabinoids in order to elucidate and characterise all the skin activities associated with these molecules.
Our teams of experts remain at your disposal to discuss and design your projects for atopic skin.
Extending our scope of baby diaper testing
Increased awareness of baby health and hygiene needs among parents is driving the growth of the baby products market across the globe. In an industry where environmental challenges, performance, and safety issues are intertwined, Eurofins Consumer Product Testing is a pioneer in the analysis of hygiene products by developing and implementing a global offering for disposable and/or reusable baby diapers.
The global leading association EDANA has launched the codex test method NWSP 360 (Nonwovens Standard Procedure) with the aim to support the nonwovens and related industries by providing transparency and reassurance for customers with regard to a defined list of trace levels of impurities found in Absorbent Hygiene Products (AHPs).
Eurofins Cosmetics & Personal Care is extending its scope of testing by offering chemical analyses of baby diapers following the EDANA Stewardship Programme on Absorbent Hygiene Products (AHPs). Some testing parameters for chemical analysis include dioxins, phthalates, pesticides, PAH, and heavy metals, etc.
Softlines & Leather
Standards updates
The below table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of withdrawal: 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 |
Leather - Measurement of leather surface - Electronic techniques (ISO 19076:2023) |
2023-08-31 |
||
Leather - Physical and mechanical tests - Determination of water vapour permeability (ISO 14268:2023) |
2023-08-31 |
||
Leather - Chemical, physical, mechanical and fastness tests - Position and preparation of specimens for testing (ISO 2418:2023) |
2023-08-31 |
||
Textiles and textile products - Microplastics from textile sources - Part 1: Determination of material loss from fabrics during washing (ISO 4484-1:2023) |
2023-08-31 |
- |
Toys, Childcare & Hardlines
New references of harmonised standards for toys
On 5th April 2023, the European Commission published the Commission Implementing Decision (EU) 2023/740 of 4 April 2023 on harmonised standards for toys drafted in support of Directive 2009/48/EC of the European Parliament and of the Council, which repeals the Implementing Decision (EU) 2021/1992.
The main points of this decision are:
- The updated references of the harmonised standards for toys are listed the annex:
No |
Reference of the standard |
||
1. |
EN 71-1:2014+A1:2018 Safety of toys — Part 1: Mechanical and physical properties |
||
2. |
EN 71-2:2020 Safety of toys — Part 2: Flammability |
||
3. |
EN 71-3:2019+A1:2021 Safety of toys — Part 3: Migration of certain elements |
||
4. |
EN 71-4:2020 Safety of toys — Part 4: Experimental sets for chemistry and related activities |
||
5. |
EN 71-5:2015 Safety of toys — Part 5: Chemical toys (sets) other than experimental sets |
||
6. |
EN 71-7:2014+A3:2020 Safety of toys — Part 7: Finger paints — Requirements and test methods |
||
7. |
EN 71-8:2018 Safety of toys — Part 8: Activity toys for domestic use |
||
8. |
EN 71-12:2016 Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable substances Informative note: The limit values in point (a) of Table 2 of clause 4.2 of standard ‘EN 71-12:2016 Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable substances’ are lower than the limit values to be complied with set in point 8 of part III of Annex II to Directive 2009/48/EC. In particular those values are as follows: |
||
Substance |
Standard EN 71-12:2016 |
Directive 2009/48/EC |
|
N-nitrosamines |
0,01 mg/kg |
0,05 mg/kg |
|
N-nitrosatable |
0,1 mg/kg |
1 mg/kg. |
|
9. |
EN 71-13:2021+A1:2022 Safety of toys — Part 13: Olfactory board games, cosmetic kits and gustative games |
||
10. |
EN 71-14:2018 Safety of toys — Part 14: Trampolines for domestic use |
||
11. |
EN IEC 62115:2020 Electric toys — Safety EN IEC 62115:2020/A11:2020 |
The below table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
(**) Date of announcement: the latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level.
CEN – Child care articles |
|||
Reference |
Title |
Date of withdrawal (*) |
Supersedes |
Child care articles - Reclined cradles - Part 1: Reclined cradles for children up to when they start to try to sit up |
2024-03-31 |
||
Child care articles - Reclined cradles - Part 2: Reclined cradles for children up to when they start to stand up |
2024-03-31 |
- |
|
Reference |
Title |
Date of Availability (**) |
Supersedes
|
Child care articles - General safety guidelines - Part 3: Mechanical hazards |
|
||
Child care articles - General safety guidelines - Part 5: Product information |
2023-04-26 |
CEN - FCM |
|||
Reference |
Title |
Date of withdrawal (*) |
Supersedes |
Cookware - Domestic cookware for use on top of a stove, cooker or hob - Part 1: General requirements |
2023-08-31 |
EN 12983-1:2000/AC:2008 |
|
Cookware - Domestic cookware for use on top of a stove, cooker or hob - Part 2: General requirements for ceramic cookware and glass lid |
2023-08-31 |
CEN – Consumer products |
|||
Reference |
Title |
Date of withdrawal (*) |
Supersedes |
Gymnastic equipment - Individual and multifunctional vaulting boxes - Safety requirements and test methods |
2023-08-31 |
- |
|
Hardware for furniture - Test methods for strength and overload tests of connectors for furniture constructed from panel material |
2023-09-30 |
|
|
Jewellery and precious metals - Determination of palladium - Gravimetry using dimethylglyoxime (ISO 11490:2023) |
2023-09-30 |
||
Jewellery and precious metals - Determination of platinum - Gravimetry using ammonium chloride (ISO 11210:2023) |
2023-09-30 |
||
Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018) |
2023-09-30 |
|
|
Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018) |
2023-09-30 |
|
|
Packaging - Test methods and requirements to demonstrate that plastic caps and lids remain attached to beverage containers |
2023-09-30 |
||
Paints and varnishes - Determination of density - Part 1: Pycnometer method (ISO 2811-1:2023) |
2023-08-31 |
||
Paints and varnishes - Determination of scratch resistance - Part 1: Constant-loading method (ISO 1518-1:2023) |
2023-08-31 |
||
Paints and varnishes - Determination of resistance to abrasion - Part 1: Method with abrasive-paper covered wheels and rotating test specimen (ISO 7784-1:2023) |
2023-08-31 |
||
Paints and varnishes - Determination of resistance to abrasion - Part 2: Method with abrasive rubber wheels and rotating test specimen (ISO 7784-2:2023) |
2023-08-31 |
||
Paints and varnishes - Vocabulary (ISO 4618:2023) |
2023-08-31 |
New safety evaluation of BPA published by EFSA and BfR
On 19th April 2023, two European entities published the following opinions regarding safety Bisphenol A (BPA):
- EFSA published a new scientific opinion on the safety of BPA. According to the safety evaluation a reduction of TDI by a factor of 20 000 was recommended. This would result in an SML of 2.5 ng/kg food, which is analytically extremely hard to achieve. Furthermore, blank values will be hardly free of BPA in such low concentrations.
- The German Federal Institute for Risk Assessment (BfR) published its own opinion, which does not support the new TDI derived by EFSA due to several scientific and methodologic divergencies. Based on a detailed analysis of the scientific data on toxicological effects from gastrointestinal (oral, via the mouth) exposure to BPA, the BfR has derived a TDI value of 0.2 micrograms (which corresponds to 200 nanograms) per kilogram body weight, which is still a factor of 20 lower than the current limit but 1,000 fold higher than the EFSA opinion.
CPSC Implements the STURDY Act Requirements for the CSU Stability
On April 19, 2023, the CPSC Commissioners voted to approve the direct final rule that implements the Stop Tip-overs of Unstable, Risky Dressers on Youth (STURDY) Act’s requirements for the stability of the clothing storage units (CSUs). The direct final rule (DFR) adopts the performance requirements of the ASTM F2057-23 as the Safety Standard for Clothing Storage Units in 16 CFR 1261, in place of the current part 1261 that the CPSC had published in November 2022 as a consumer product safety standard for CSUs to protect children from tip-over-related death or injury, that otherwise will take effect on May 24, 2023.
The direct final rule was published on May 4, 2023 and will go in effect on September 1, 2023, unless the CPSC receives significantly adverse comments by June 5, 2023. The final rule will apply to the CSUs manufactured on and after the effective date.
Scope: With adoption of ASTM F2057-2023, the scope of the CSU stability requirements will be “free-standing clothing storage units, including but not limited to chests, chests of drawers, drawer chests, armoires, chifferobes, bureaus, door chests, and dressers, which are 27 in. (686 mm) or greater in height, 30 lb (13.6 kg) or greater in mass, and contain 3.2 ft3 (90.6 dm3) or greater of enclosed storage volume.
The scope excludes shelving units, such as bookcases or entertainment furniture, office furniture, dining room furniture, jewelry armoires, underbed drawer storage units, occasional/accent furniture not intended for bedroom use, laundry storage/sorting units, or built-in units intended to be permanently attached to the building, nor does it cover “Clothing Storage Chests” as defined in Consumer Safety Specification ASTM F2598.
Certification: The CSUs manufactured after the effective date will require Certification as per the 16 CFR 1110 rule. In addition, the children’s CSUs will require testing at a CPSC accepted third-party lab for the Certification (CPC) as per the 16 CFR 1110 rule.
Direct final rule: https://www.govinfo.gov/content/pkg/FR-2023-05-04/pdf/2023-08997.pdf
A copy of the ASTM F2057-2023 standard can be purchased at ASTM website.
SAMR issued Supervision and Management Measures for Toothpastes
On 23rd March 2023, the China State Administration for Market Regulation (SAMR) issued a regulation Supervision and Management Measures for Toothpastes. The new regulation will come into effect on 1st December 2023.
In accordance with the regulation, the toothpaste is defined as a paste-like product that is applied to the surface of human teeth by friction for the main purpose of cleaning.
The key points are as follows:
- The regulation clarifies the toothpastes and toothpaste raw material specific management requirement
- The toothpastes will continue to implement a production licensing system and, issue cosmetic production licenses
- The toothpaste applicant shall publish a summary of the literature, research data or product efficacy evaluation data on which the efficacy claim is based at the time of filing
- The regulation clarifies the labelling requirement on label annotation information and prohibited content:
- The label on toothpaste products shall include the following information:
- Product name
- Name and address of the recordation applicant or entrusted production enterprise, and where the filing person is overseas; the name and address of the responsible person within the territory shall also noted
- Name and address of the manufacturer, and domestic toothpaste shall be marked with the production license number of the manufacturer
- Standard product implementation number
- Full ingredients list
- Net content
- The period of use
- Necessary safety warning language
- Other content that laws, administrative regulations, and mandatory national standards provide shall be marked
- According to the characteristics of the product, if it is necessary to specifically label the method of use of the product, this shall be marked on the visual surface of the sales package.
- The following contents are prohibited on toothpaste labels:
- Content that explicitly or implicitly claims a medical effect
- Content that is false or misleading
- Content that violates social order and good customs
- Other content prohibited from labelling by laws, administrative regulations, mandatory national standards, and technical specifications.
- The label on toothpaste products shall include the following information:
To view the official source, please click here (in Chinese ONLY)
Proposal to amend the Cosmetics Products Group Standard 2020
On 14th March 2023, the Environmental Protection Authority (EPA) of New Zealand notified the WTO of a proposal to amend the cosmetics product group standard 2020 (the Group Standard). The public comments were open until March 31st, 2023.
Considering the potential harm to the environment and consumers causes by so called ‘forever chemicals’, the new proposal introduces a future ban on PFAS and additional requirements for nanomaterials, and integrates the latest IFRA Standards.
According to the notification content, the proposal to amend the Group Standard includes:
- Update lists of cosmetic ingredients subject to certain rules (including those that are banned/restricted) to be consistent with current annexes of EU Cosmetics Products Regulation (Regulation (EC) No 1223/2009)
- Expand the scope of the Group Standard to require products that are not hazardous in themselves but do contain a hazardous component to comply with the Group Standard
- Introduce a phase-out of cosmetic products contained perfluoroalkyl and polyfluoroalkyl substances (PFAS) by 31 December 2025
- Update requirements to adhere to the International Fragrance Association (IFRA) Standards to reference the 50th amendment of those standards, and any subsequent versions
- Providing for appropriate transitional arrangements
- Several other minor drafting changes
ISO 8124-3:2020/Amd.1:2023 New impact for migration of heavy metals
On 23rd March 2023, the International Organization for Standardization (ISO) Technical Committee: ISO/TC 181 issued a new amendment ISO 8124-3:2020/Amd.1:2023 for toy safety standards regarding heavy metal. The amendment will come into effect as long as the standard issued.
The main points of the new amendment are as follows:
- Add new definition of Slime: Water-based gel or gel-like material, clear or coloured, which is viscous, slippery, and often non-Newtonian fluids, intended for play by hand manipulation, kneading and stretching.
- Combine the putty definition into modelling clay as "Modelling Clay and Putty": Flexible solid or semi-solid mixtures that retain their shape and form when moulded into a shape, intended to create representations of objects by hand manipulation or to be extruded into profiles by the toy.
- Add element Boron (B) migration limit for Slime and Modelling Clay and Putty:
Slime: 1250 mg/kg
Modelling Clay and Putty: 3750 mg/kg
- Adjust specific element migration limit for Slime and Modelling Clay and Putty:
Slime: The migration limits for all eight elements align with those of finger paint
Modelling clay and Putty: The element Barium (Ba) migration limit is 350 mg/kg
Below are the new limits laid out by the amendment:
New limit of ISO 8124-3:2020/Amd.1:2023
Toys material |
Element Limit(mg/kg) |
||||||||
Antimony (Sb) |
Arsenic (As) |
Barium (Ba) |
Cadmium (Cd) |
Chromium (Cr) |
Lead (Pb) |
Mercury (Hg) |
Selenium (Se) |
Boron (B) |
|
Any toy material given in Clause 1,except modelling clay and putty, finger paint, and slime |
60 |
25 |
1000 |
75 |
60 |
90 |
60 |
500 |
-- |
Finger paint |
10 |
10 |
350 |
15 |
25 |
25 |
10 |
50 |
-- |
Slime |
10 |
10 |
350 |
15 |
25 |
25 |
10 |
50 |
1250 |
Modelling clay and putty |
60 |
25 |
350 |
50 |
25 |
90 |
25 |
500 |
3750 |
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 |
Argentina |
Draft MERCOSUR Technical Regulation on silicones intended for the manufacture of materials, packaging, linings and equipment in contact with food (P. RES No. 06/22) The notified draft technical regulation applies to silicones used in materials, packaging, linings and equipment that come into contact with food. It does not apply to linings intended for cellulosic materials, which must comply with another specific MERCOSUR Technical Regulation. |
|
Kingdom of Saudi Arabia |
Technical Regulation for Packaging This regulation specifies the following: Terms and Definitions, Scope, Objectives, Supplier Obligations, Labelling, Conformity Assessment Procedures, Responsibilities of Regulatory Authorities, Responsibilities of Market Surveillance Authorities, Violations and Penalties, General Provisions, Transitional Provisions, Publishing Appendix (lists of standards, HS code, List, the Identification System for Packaging Materials, Conformity Assessment Forms (Supplier Declaration of Conformity) |
|
UK |
The Environmental Protection (Plastic Plates etc. and Polystyrene Containers etc.) (England) Regulations 2023 These regulations will introduce a ban on the supply of:
The restriction will not apply to:
|