CIRS Regulatory Newsletter #4 March 2024
This issue brings you the latest chemical, cosmetic and food regulation news including:
We are also highlighting our upcoming free webinars, including
You can find out more about our free webinars below.
Chemical News
ECHA Consults on Adding Two Substances into the SVHC List
On March 1, 2024, ECHA released two substances proposed to be added into the SVHC Candidate List for public consultations. Comments are welcomed before April 15, 2024.
These two substances are:
Find out more details via the link below.
ECHA Conducts Compliance Checks on Over 20% of REACH Registration Dossiers
The European Chemicals Agency (ECHA) has performed compliance checks of approximately 15000 registrations between 2009 and 2023, representing 21 % of full registrations. It is a significant increase compared with 5% in 2019.?At the same time, ECHA has also conducted compliance checks on 30% of high-tonnage registered substances (annual production of more than 100 tons).
In 2023, 301 compliance reviews were conducted on more than 1750 REACH registration dossiers involving 274 substances, aiming to supplement potentially missing information to improve the safety of these chemical substances. Thus far, ECHA has made more than 251 data supplement requests to a number of companies.
Find out more details via the link below.
US EPA Adjusted the TSCA Fees
On Feb 8, 2024, the U.S. Environmental Protection Agency (EPA) announced its final rule on revising the Toxic Substances Control Act (TSCA) fee. The revised fees will be effective 60 days after the 2024 final rule is published in the Federal Register.
Find out more details via the link below.
110 GB Biocidal Active Substances are Postponed until 2027
In February 2024, UK's Health and Safety Executive (HSE) announced that the expiry date of all biocide active substances expiring between 1 January 2024 and 31 December 2026 would be extended to 31 January 2027. This amendment impacts up to 110 active substances, with the expiration dates of 46 active substances formally prolonged.
Find out more details via the link below.
23 New Chemical Substances Added to the TSCA Inventory
On February 22, 2024, the US Environmental Protection Agency (EPA) updated its Toxic Substances Control Act (TSCA) Inventory for the first half of 2024. The updated TSCA Inventory contains a total of 86,741 chemical substances, of which 42,293 are active. The latest update adds 23 new chemicals compared to the August 2023? Inventory. The TSCA Inventory is updated biannually to keep chemical information current and accurate.
Find out more details via the link below.
2024 CIRS Spring Global Chemical Regulation Webinar Series - EU, UK, China and South Korea
Chemical regulations are an ever-evolving landscape, and can be difficult to keep up to date with the requirements across the global marketplace. CIRS is committed to ensuring that everyone remains informed of the latest implementation of these regulations, removing barriers to trade, and ensuring that their business can flourish around the world. Whether you are new to chemical regulations, interested in exploring a new market, or seeking a refresher in this area our series will give you the opportunity to broaden your knowledge and deepen your understanding in all these areas.
Each webinar will be hosted?every Thursday?from February 29 to March 28, 2024,?at 14:00 (GMT) and you can join us free of charge via the link below.
If you missed our previous topics, you can also watch the playback free and on-demand here.
Free Webinar: How to Submit the Poison Centre Notification (PCN)?
Starting from January 1, 2024, the transition period established by the European Union for the PCN notification of mixtures for industrial use has also ended. All hazardous mixtures for professional, consumer, and industrial uses, such as those classified under GHS with specific physical or health hazards, are required to complete PCN notification before being placed on the EU market.
This webinar aims to guide enterprises in determining whether PCN notification is necessary and in interpreting the UFI number.
Main contents cover:
This webinar will be hosted on March 22, 2024, at 13:00 (EST).
Food and food contact materials news
【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China -Probiotics
Adding probiotics in infant formula plays a positive role in nurturing healthy gut microbiota in infants. It not only helps build a robust community of beneficial bacteria but also effectively curbs the growth of harmful ones, steering the baby’s gut microbiota structure closer to the ideal state observed in breastfed infants.
So, what are the requirements for registering infant formula adding probiotics? To give businesses a clear picture, CIRS Group provides detailed analyses in conjunction with relevant infant formula regulations and Q&A guidelines.
Find out more details via the link below.
China NHC Released 47 National Food Safety Standards including GB 2760-2024 and 6 Amendments
On March 12, 2024, the National Health Commission (NHC) and the State Administration for Market Regulation (SAMR), in accordance with the provisions of the Food Safety Law of the People’s Republic of China, jointly issued Notice No. 1 of 2024, releasing 47 new national food safety standards and 6 amendment notes.
These standards mainly include:
Find out more details via the link below.
EU Proposed a Ban on the Use of BPA in FCMs
On Feb 9, 2024, the European Commission proposed a new draft aimed at amending the existing regulations on food contact materials (FCMs), involving a ban on bisphenol A (BPA) and its derivatives. The draft amends (EU) No 10/2011 and (EC) No 1895/2005, and repeals (EU) 2018/213.
What is BPA?
Bisphenol A (BPA), known as 4,4'-dihydroxydiphenylpropane (CAS No: 80-05-7), is a monomer or starting substance widely used in the manufacture of polycarbonate, polysulfone, epoxy resins, and other resins. It is extensively used in plastics, varnish coatings, inks, adhesives, and rubbers.?
Find out more details via the link below.
领英推荐
China CFSA Collects Public Comments on Three New Food Raw Materials
On March 1, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 3 new food raw materials, namely maritime pine bark extract, Bifidobacterium longum subsp. infantis M-63 and N-acetylglucosamine for public comments. Comments are welcomed before April 1, 2024.
Find out more details via the link below.
Free Webinar: Interpretation of the Latest Regulations regarding Health Food and Requirements for Replacement of Old Certificate
Since 2023, the State Administration for Market Regulation (SAMR) has been rolling out a series of regulations on health food. The long-awaited health food functions catalog, evaluation methods for health food functions, and implementation details for new health food function applications have finally been established, offering hope for revitalizing the long-dormant market. Against the backdrop of current regulations, the change of health food registration certificate process is about to commence.
This webinar aims at introducing the latest regulations regarding health food, to assist businesses in gaining a better understanding of health food regulatory requirements. Major contents cover:
The webinar will be hosted on Tuesday, April 16, 2025, at 14:00 (GMT).
Free Webinar: U.S. GRAS Pathway for Food Ingredients
The U.S. is an expansive market for new food ingredients but accessing it takes knowledge about its regulatory requirements. Generally Recognized as Safe (GRAS) substantiation is one common regulatory pathway businesses can choose to ensure their ingredient complies with U.S. standards. We will cover important points that are unique to the U.S. GRAS process and that need to be considered for long-term business success.
Join CIRS for an insightful and comprehensive webinar on Thursday, April 18, 2024 at 9:00 (GMT+8) on how GRAS status can help your company’s ingredients make it to the U.S. marketplace faster.
Contact Ms. Cathy Yu at [email protected] to register.
Personal and home care news
2024 UK China Forum for Collaboration on Innovative Ingredients for a Sustainable Future
The UK's Department for Business and Trade (DBT) will join hands with a number of British companies to attend the China Personal Care and Homecare Ingredients Exhibition (PHCi) held from March 20-22, 2024. During this time, DBT will also partner with CIRS Group to co-host the 2024 UK China Forum for Collaboration on Innovative Ingredients for a Sustainable Future on March 20, and invite a number of leading UK companies to share innovative technologies and products, explore ways to achieve sustainable development in the field of personal care chemicals.
This forum, aiming at promoting the exchanges and collaboration in the personal care industry between China and the UK, mainly focuses on the sustainable development of the personal care industry, insight into the UK's personal care industry, a dialogue over a sustainable future for the personal care industry, etc.
Find out more details via the link below.
CIRS to Host the 2024 - Seoul Global Cosmetics (US, Japan, Europe) Regulation and Advancement Seminar
CIRS Europe will partner with CIRS Group Korea and the Korea Cosmetic Industry Institute (KCII) to co-host the?2024 - Seoul Global Cosmetics (US, Japan, Europe) Regulation and Advancement Seminar?on Tuesday, March 19, 2024.
Time: 13:30 ~ 17:30, March 19, 2024 (Tuesday)
Location: 51st floor, Seoul Trade Association, South Korea
Organizer:?CIRS Europe, CIRS Group Korea and KCII
Registration Fee: Free
Language: English and Korean
Find out more details via the link below.
Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 54)
We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.
1. When using new ingredients for the production of cosmetics, what should the filer pay attention to?
2. How should the multi-color series of makeup products be registered?
3. If toxicological tests are not exempted, what products should undergo an acute eye irritation test?
Find out more details via the link below.
Longer reads
Frequently Asked Questions about FDA Generally Recognized As Safe (GRAS) Certification, Vol. 1
With the development of the food industry, there has been a growing emergence of new technologies and substances in recent years. Meanwhile, there is an increasing demand from food companies to seek new food ingredient compliance, including the GRAS certification in the United States. This article aims to address common questions about the food substance classification under the FDA GRAS, covering topics such as whether the use of a certain substance in human or animal food shall be classified as GRAS, and GRAS application compliance, among others.
Q1: What does FDA GRAS mean?
A1: “GRAS” is an acronym for the phrase Generally Recognized As Safe, which stands as an important food substance category in the United States. If a substance is generally recognized to be safe under the conditions of its intended use among qualified experts through scientific procedures, then it can be recognized as GRAS.
Under the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by the FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive. Therefore, due to its convenient process and high international recognition, GRAS certification has become one of the important application projects for food enterprises to access international markets.
Q2: How should a food enterprise choose between Self GRAS and FDA GRAS?
A2: The notifier’s decision to submit a GRAS notice to CFSAN or CVM is voluntary, and the FDA’s response is not approved. It can be categorized into the following two types:
Self GRAS (Self-affirmed?GRAS)
It only requires recognition from qualified experts demonstrating the safety of the substance, without submitting a notice to the FDA and without undergoing FDA review, thus it will not be publicly disclosed. This streamlined process shortens the procedure for developing and applying new products, allowing for earlier market release and sales.
FDA GRAS (FDA GRAS Notification)
Formal submission to the FDA is required, followed by an official FDA review. Substances approved will be publicly listed on the official website, adding authoritative validation. This serves as a strong endorsement for Chinese food enterprises when applying for domestic new food materials, providing evidence of the international usage background of the product.
Q3: If an ingredient is GRAS for one use, is it GRAS for all uses?
A3: Not necessarily. It is the use of a substance, rather than the substance itself, that is eligible for classification as GRAS.
Some uses of a human food substance are intended for a narrowly defined population. For example, some human food substances are intended for consumption by newborn infants who consume infant formula as the sole item of the diet. Likewise, some substances intended for use in animal food are intended for specific animal species, or for a specific life stage of an animal species; a substance that is safe for use in one animal species may not be safe for use in another species or in the same species at a different stage of life.
Q4: Is a substance that is used to impart color eligible for classification as GRAS?
A4: The short answer is “No.” To put it simply, the use of a substance capable of imparting color may constitute use as both a color additive and as a food additive or GRAS substance.
(Under 21 CFR 70.3(g), a material that otherwise meets the definition of color additive can be exempt from that definition on the basis that it is used or intended to be used solely for a purpose or purposes other than coloring, as long as the material is used in a way that any color imparted is unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. )
In other words, if a substance is intended to be used solely for a purpose or purposes other than coloring, it can be exempted from the definition of a color additive and can undergo GRAS certification. However, if the intended use includes “coloring” purposes (even if not the primary purpose), it falls under the definition of a color additive. Therefore, a color additive petition is required for its compliant use. For example, betacarotene is both approved for use as a color additive and affirmed as GRAS for use as a nutrient in human food by FDA; in some food products, beta-carotene may be safely and lawfully used for both purposes.
Q5: If I submit a GRAS notice about a substance intended for use in human or animal food, must I wait until I receive an official response of “No questions” before I market that substance in the United States?
A5: No. Your decision to submit a GRAS notice to CFSAN or CVM is voluntary. If you are correct in concluding that a substance is GRAS under the conditions of its intended use, you may market a substance that is GRAS under the conditions of its intended use without informing CFSAN or CVM or, if CFSAN or CVM is so informed, while the applicable Center is evaluating your GRAS notice.
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