May this holiday season bring joy and success to you. Merry Christmas and Happy New Year!
Holiday Notice:
CMA Industrial Development Foundation Limited:
Please be informed that our office will be closed from 24 Dec to 26 Dec 2023 and operations will be resumed on 27 Dec 2023 .
The Ministries of Japan published Cabinet Order No. 343 of 2023, which amends the Act on the Evaluation of Chemical Substances and Regulation of their Manufacturer etc., on 1 December 2023. The proposed order restricts the utilization of PFHxS, its salts, and their isomers in the following products. This order will go into force on 1 February 2024.
Beginning on 1 June 2024, the following products containing PFHxS, its salts, and its isomers will not be allowed for importation.
- Water resistant and oil resistant textile;
- Etching agent used for metal processing;
- Etching agents used in the manufacture of semiconductors;
- Surface treatment agent for plating or preparation;
- Antireflection agent for use in semiconductor manufacturing;
- Resist for semiconductor.
- Water repellent, haze oil and fiber protecting agent;
- Fire extinguisher, fire-extinguishing agent, and fire-extinguishing foam;
- Water resistant and oil resistant clothes;
- Water repellent and oil repellent floor covering;
You can refer to the regulation here for more details.
The Nuremberg International Toy Fair 2024
Date: 30th January 2024 to 3rd February 2024
Venue: Nuremberg Exhibition Center
Booth: A-73
CMA Testing is delighted to join this 4-day mega event and showcase our diverse testing services to visitors from all around the world.
Sources and Hazards of Microplastics
There are two sources of microplastics (i.e. synthetic polymer microparticles), Primary Microplastics and Secondary Microplastics. The former is purposefully added during the product production process to increase its product functions. It is often used in personal care products, cosmetics and detergents, such as whitening toothpaste, exfoliating facial cleanser, washing beads, etc. The latter is formed unintentionally, due to the decomposition of large pieces of plastic waste, the wearing and tearing of tires and road paint, or the washing of synthetic clothing.
The main hazards of microplastic:
- Microplastics in the environment such as soil, rivers, lakes and oceans, causing pollution to our ecological system;
- Microplastics have small particle size with large in area, and strong adsorption capacity. They are carriers for the transfer of toxic and harmful substances;
- Microplastics in our ecological system then enter the human body by food intake, drinking water, skin contact, etc. After entering the human body, they can be excreted but remain in certain extent. The microplastics remaining in the human body will not be degraded by the human body, causing serious harm to human health.
Restriction on Microplastics in EU
On September 27, 2023, the European Union published Commission Regulation (EU) 2023/2055 amending Annex XVII of REACH Regulation in its Official Journal, adding entry 78 as regards synthetic polymer microparticles (i.e. microplastics) to the list of Annex XVII. The new requirements entered into force on 17 October 2023.
The definition of microplastics in Commission Regulation (EU) 2023/2055:
Solid polymer and which fulfil both of the following conditions:
- are contained in particles and constitute at least 1 % by weight of those particles; or build a continuous surface coating on particles;
- at least 1 % by weight of the particles referred to in point (a) fulfil either of the following condition:
- all dimensions of the particles are equal to or less than 5 mm;
- the length of the particles is equal to or less than 15 mm and their length to diameter ratio is greater than 3.
The following polymers are excluded from the above definition:
- Polymers that are the result of a polymerisation process that has taken place in nature, independently of the process through which they have been extracted, which are not chemically modified substances;
- Polymers that are degradable as proved in accordance with REACH Appendix 15;
- Polymers that have a solubility greater than 2 g/L as proved in accordance with REACH Appendix 16;
- Polymers that do not contain carbon atoms in their chemical structure.
Limit Requirements for Microplastics
| Microplastics | Scope | Requirements |
| Substance | Prohibited | |
| Mixtures | <0.01% 1 (by weight) where the microparticles are present to confer a sought-after characteristic 2 |
1 The concentration of microplastics cannot be determined by available analytical methods or accompanying documentation, in order to verify the compliance with the concentration limit, only the particles of at least the following size shall be taken into account:
- 0.1 μm for any dimension, for particles with ≤ 5 mm in all dimensions
- 0.3 μm in length, for particles with a length ≤15 mm and a length to diameter ratio greater than
2 It means concerning the intentional added microplastics, while not concerning unintentionally generated microplastics.
Exemptions from the above Limit Requirements
Exemption of synthetic polymer microparticles, as substances on their own or in mixtures:
- Synthetic polymer microparticles which are contained by technical means so that releases to the environment are prevented when used in accordance with the instructions for use during the intended end use;
- Synthetic polymer microparticles the physical properties of which are permanently modified during intended end use in such a way that the polymer no longer falls within the scope of this entry;
- Synthetic polymer microparticles which are permanently incorporated into a solid matrix during intended end use.
The following products are exempted:
- Synthetic polymer microparticles, as substances on their own or in mixtures, for use at industrial sites;
- Medicinal products within the scope of Directive 2001/83/EC and and veterinary medicinal products within the scope of Regulation (EU) 2019/6;
- EU fertilising products within the scope of Regulation (EU) 2019/1009;
- Food additives within the scope of Regulation (EC) No 1333/2008;
- In vitro diagnostic devices, including devices within the scope of Directive (EU) 2017/746;
- Food within the Article 2 of Regulation EC) No 178/2002, and feed as defined in Article 3(4) of that Regulation.
Although the limit requirements are exempted, suppliers of synthetic polymer particulate products containing the above exempted limit requirements should follow the Regulation (EU) 2023/2055 requires relevant product information and declarations.
Effective Date
Except for specific products, the new restrictions have entered into effect on October 17, 2023. Effective dates for specific products are as follows:
Verifications for exemption categories are:
| Clauses | Restricted Products | Products Definitions | Effective Date |
| 6 (a) | encapsulation of fragrances | – | 17 October 2029 |
| 6 (b) | rinse-off products | point (1)(a) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009 | 17 October 2027 |
| 6 (c) | lip products | point (1)(e) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009 | 17 October 2035 |
| nail products | point (1)(g) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009 | 17 October 2031 – 16 October 2035 : nail products and make-up products with labeling: “This product contains microplastics.” | |
| make-up products | |||
| 6 (d) | leave-on products | point (1)(b) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009 | 17 October 2029 |
| 6 (e) | detergents, waxes, polishes and air care products | Article 2(1) of Regulation (EC) No 648/2004 | 17 October 2028 |
| 6 (f) | medical devices | Regulation (EU) 2017/745 | 17 October 2029 |
| 6 (g) | fertilizing products | Article 2, point (1), of Regulation (EU) 2019/1009, which do not fall within the scope of that Regulation; | 17 October 2028 |
| 6 (h) | plant protection products | Article 2(1) of Regulation (EC) No 1107/2009 | 17 October 2031 |
| seeds treated with those products, and biocidal products | Article 3(1), point (a), of Regulation (EU) No 528/2012 | ||
| 6 (i) | products for agricultural and horticultural uses | not covered by points (g) or (h) | 17 October 2028 |
| 6 (j) | granular infill for use on synthetic sports surfaces | – | 17 October 2031 |
- Verify non- microplastics, test and verify particles size to see whether they belongs to the microplastics defined in entry 78 of REACH Annex XVII.
- Verify biodegradability, such as OECD TG 310, EN ISO 14852:2021, etc.
- Verify solubility, such as OECD Guideline 120, OECD Guideline 105.
- Verify carbon atoms. By definition, microplastics do not contain carbon atom structures and are not subject to the (EU) 2023/2055 microplastics restriction order.
Ban of Plastic Glitter
Glitter is often added to daily products, such as nail polish, eye shadow, lip gloss, etc.; it is also used in toy products such as crystal mud, glitter DIY toys, toy cosmetics, and is also often used in textiles and clothing. A decorative element that can be used to add brightness and color to clothing, makeup and toys.
However, plastic glitter on its own (also called loose plastic glitter) is to be regarded as a mixture under REACH and therefore is in the scope of Regulation (EU) 2023/2055. Currently, the European Commission is expected to publish a detailed Q&A document on microplastics by the end of 2023 to help with the implementation of the new rules. At the same time, the European Commission issued a guidance document on glitter products (detailed requirements on glitter products will also be added to the Q&A document expected to be released at the end of the year).
Why Does The EU Want to Ban Plastic Glitter?
The purpose is not to ban all glitter but replace plastic glitter with more environmentally friendly glitter that does not pollute our oceans. The determining factors for the EU’s restriction of plastic glitter are the following three aspects:
- One is the composition: Only glitter made of non-biodegradable, insoluble is concerned. Glitter made from biodegradable, soluble, natural or inorganic materials is not considered microplastics and can continue to be sold.
- The second is the uses: The use of non-biodegradable, insoluble plastic glitter in products without a transition period and is banned as of 17 October 2023, for example art and crafts, toys, textiles (with certain exceptions). Glitter used in cosmetics and detergents (and for other uses benefiting from a specific transitional periods under paragraph 6 of the restriction) can continue being sold until the end of that period.
- The third is the molding method (loose or trapped or affixed glitter): Plastic glitter is not affected by the ban if, when used, it is trapped in a solid matrix (e.g. glitter glue), solid films (e.g. paints, inks) or solid objects (e.g. inside jewellery, spray can caps, etc.) or is fully contained (e.g. in snow globes). Concerning plastic glitter that is affixed to objects, the sale ban would apply as of 17 October 2023 only to glittered decorative objects (such as – but not limited to – Christmas decorations or party hats) from which glitter detaches during normal use.
There are exceptions that are not concerned by the restrictions:
- Products, including glitter, made of material that is inorganic (e.g. glass, metal), natural, biodegradable or soluble in water (out of scope as they are not considered microplastics).
- Beads and sequins (and other decorations) intended to be threaded or sewn.
- Microplastics, including plastic glitter, that contained by technical means (e.g. enclosed in snowballs) or permanently incorporated in a solid matrix (e.g. trapped in glue, paints or inks, or inside solid objects).
- In case of glittered articles for which the decorative function is secondary – such as textiles used for garments or footwear, glitter is always regarded as an integral part of the article. These glittered articles – eg: clothing, shoes, curtains – are out of the scope of the restriction.
For glittered articles having a purely decorative function, or for which the decorative function is the main function of the article – such as textiles used in certain art and craft kits, toy/party hats, Christmas decorations, etc. – glitter can only be regarded as an integral part of the article if it does not detach from the article during normal end use (including storage). In case glitter detaches from the article during normal end use, the glittered article is to be regarded as a combination of an article (e.g. the article without the glitter) and a mixture (the glitter). In the latter case, the ban applies to the glitter (but in practice, the whole glittered article cannot be sold).
Introduction to TPCH Regulations
TPCH (Toxics in Packaging Clearinghouse) was established in 1992. Its predecessor was CONEG. It is responsible for promoting the “Model Toxics in Packaging Legislation” in various states in the United States and supporting & coordinating the implementation of the regulation. Due to the successful promotion of this regulation by TPCH, people often refer to the US regulations for the control of hazardous substances in packaging materials as TPCH.
The TPCH regulation restricts the entire packaging supply chain, including manufacturers, suppliers of packaging and packaging components, and manufacturers or distributors of products that use packaging. This model regulation needs to be adopted by each state in the United States before it will take effect in the corresponding state. TPCH regulation have been adopted by 19 states in the United States, and packaging materials exported to these 19 states need to meet TPCH requirements. These 19 states include: California, Connecticut, Florida, Georgia, Illinois, Iowa, Maryland, Maine, Minnesota, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin.
Package definition in TPCH regulation:
- A container providing a means of marketing, protection or handling of a product and shall include a unit package, an intermediate package and a shipping container as defined in American Society for Testing and Materials ASTM D996.
- Package shall also mean and include such unsealed receptacles as carrying cases, crates, cups, pails, rigid foil and other trays, wrappers and wrapping films, bags and tubs.
Packaging component definition in TPCH regulation:
- Any individual assembled part of a package such as, but not limited to, any interior or exterior blocking, bracing, cushioning, weatherproofing, exterior strapping, coatings, closures, inks and labels
- Tin-plated steel that meets the ASTM A623 shall be considered as a single package component.
- Electro-galvanized coated steel and hot dipped coated galvanized steel that meets the ASTM A653, ASTM A924, ASTM A879 and ASTM A591 shall be treated in the same manner as tin-plated steel.
2021 Update to TPCH
On February 16, 2021, the “Model Toxics in Packaging Legislation” was updated (TPCH regulation). The 2021 update included the addition of the class of perfluoroalkyl and polyfluoroalkyl substances (PFAS) and ortho-phthalates as regulated chemicals on the original four heavy metal requirements.
2021 update to TPCH regulation link: https://toxicsinpackaging.org/model-legislation/model/
| Restricted Substances | Requirements | Remark |
| Lead（Pb）、Cadmium（Cd）、Mercury（Hg）and Hexavalent chromium（Cr6+） | The sum of four heavy metals ≤ 100ppm(0.01％,by weight) | Prohibit the intentional use of four heavy metals in any finished package or packaging component. The sum of the concentration levels of four heavy metals incidentally present in any package or packaging component shall not exceed 100 parts per million by weight (0.01%) |
| Phthalates | The sum of phthalates ≤ 100ppm (0.01％, by weight) | Refers to all phthalate organic chemicals and contains 2 carbon chains in the ortho position. |
| Per-and polyfluoroalkyl substances （PFAS） | There shall be no detectable | Refers to all fluorinated organic chemicals containing at least one fully fluorinated carbon atom (-CF2-). |
Each state will add corresponding newly identified chemical substances of concern for control based on their own circumstances, and formal implementation will begin two years after the announcement.
TPCH Updated Exemptions
All packages and packaging components shall be subject to this Act, unless, an individual state adopts into their law, any or all of the below exemptions, which shall then apply only in that state.
- Packaging or packaging components that intentionally add lead, cadmium, mercury, or hexavalent chromium to comply with health or safety requirements under state or federal law may apply for an exemption from the state administrative agency.
- There is no feasible alternative, an exemption may be requested from the state administrative agency.
Identification and Prohibition of packaging chemicals of high concern in the updated regulation:
- A carcinogen, a reproductive or developmental toxicant or an endocrine disruptor; or Persistent, bioaccumulative and toxic (PBT); or Very persistent and very bioaccumulative (vPvB); or Persistent mobile and toxic (PMT); or Very persistent and very mobile (vPvM);
- A state administrative agency determines that there is strong and reliable scientific evidence that the chemical is a reproductive or developmental toxicant, an endocrine disruptor, or a human carcinogen;
- The state administrative agency determines that there is strong credible scientific evidence that the chemical meets one or more of the following additional criteria:
- The chemical has been found through biomonitoring studies to be present in human blood, human breast milk, human urine or other human bodily tissues or fluids;
- The chemical has been found through sampling and analysis to be present in packaging;
- The chemical has been added to or is present in a package.
TPCH Certificate of Compliance
A Certificate of Compliance stating that a package or packaging component is in compliance with the requirements of this Act shall be furnished by its manufacturer or supplier to the purchaser of the packaging or packaging component. Where compliance is achieved under any state exemption(s), the Certificate of Compliance shall state the specific basis upon which the exemption is claimed. Certificates must be supported by documentation demonstrating compliance (e.g. test reports).
Guidance Document for TPCH
In November 2023, TPCH issued guidance document on PFAS (perfluoroalkyl and polyfluoroalkyl substances) and Ortho-Phthalates in Packaging in Support of the 2021 Update to Toxics in Packaging Clearinghouse Model Legislation.
Guidance document link: https://toxicsinpackaging.org/guidance-for-tpch-2021-model-legislation-update/
The best source of information about whether a package contains intentionally added PFAS is likely to be the manufacturer or supplier of the packaging. To determine if PFAS is intentionally added to any of the materials in packaging/product, TPCH recommends the following three options:
- Ask suppliers for full material disclosure—a list of all the materials and substances in the components or material.
- Ask suppliers to disclose if PFAS chemicals are added. If full material disclosure isn’t possible, ask if any PFAS chemicals are added – they’re commonly used for oil and grease resistance. Some PFAS can also be added to plastics that are then added to packaging. Some high-density polyethylene (HDPE) and polypropylene (PP) containers are treated with fluorine gas and are known as ‘fluorinated containers.’ TPCH recommend ask if containers are fluorinated
- Look for third-party certifications.
The PFAS guidance document also points out that if the total fluorine content of the package/product or component is tested, and the results are less than 100 ppm and quality control criteria are met, it is considered that PFAS may not be intentionally added and would likely comply with TPCH restrictions in packaging. But guidance suggests that regardless of the total fluorine (TF) or total organic fluorine (TOF) levels tested, manufacturers should confirm information with their suppliers:
- Confirm PFAS isn’t intentionally added.
- Identify unintentional sources of PFAS so they can try to reduce or eliminate them.
- Identify sources of inorganic fluorine (which are not PFAS).
Below are Ortho-Phthalates that are commonly analyzed using SW 846 Method 8270
The guidance document also suggests Ortho-phthalates are a subset of semivolatile organic compounds, and as such can be determined using SW 846 Method 8270.
| Chemicals | Abbreviation | CAS Number |
| Bis(2-ethylhexyl)phthalate | DEHP | 117-81-7 |
| Butyl benzyl phthalate | BBP | 85-68-7 |
| Dicyclohexyl phthalate | DCHP | 84-61-7 |
| Diethyl phthalate | DEP | 84-66-2 |
| Diisobutyl phthalate | DIBP | 84-69-5 |
| Di-isodecyl phthalate | DIDP | 26761-40-0 |
| Di-isononyl phthalate | DINP | 28553-12-0 |
| Dimethyl phthalate | DMP | 131-11-3 |
| Di-n-butyl phthalate | DBP | 84-74-2 |
| Di-n-hexyl phthalate | DHEXP/DNHP | 84-75-3 |
| Di-n-octyl phthalate | DNOP | 117-84-0 |
| Dipentyl phthalate | DPENP/DnPP | 131-18-0 |
Compliance Recommendations in TPCH Guidance Document
Compliance recommendations for product manufacturers, brand owners and retailers of packaging materials are:
- Require Certificate of Compliance for all packaging materials and their components from all suppliers in any contract or bid specification.
- Ask for criteria used to determine compliance.
- If material formulations change from suppliers require updated information.
- Prepare Certificate of Compliance based on packaging supply chain information and identify appropriate authorized signer.
- Maintain records indefinitely by working with your Risk Management policies.
Compliance recommendations for packaging material formulators and suppliers are:
- Identify regulated materials in chemical formulation or in the supplied chemical inputs.
- Identify potential incidental additions of regulated chemicals or contaminants in the manufacturing process.
- Test for baseline information on regulated chemicals or contaminants.
- Require Certificate of Compliance for all packaging materials and their components from all suppliers in any contract or bid specification.
- Ask for criteria used to determine compliance.
- If material formulations change from suppliers require updated information.
- Prepare Certificate of Compliance based on packaging supply chain information and identify appropriate authorized signer.
- Maintain records indefinitely by working with your Risk Management policies