CIRS Group regulatory news – #4 March 2023
This issue brings you several updates including Health Canada's plans to update the cosmetic ingredient hotlist, New York State's prohibition on the Use of 1,4-dioxane or Mercury in Cosmetics, FAQs on Health Food Registration and Filing in China, and China's new approvals of food raw materials, additives, and food-related products.
Throughout March and April, we will present many free webinars including:
Registrants to these webinars will gain access to a free one-hour consultation with a member of our team.
We also bring you long-form articles on:
Don't miss out on an early bird ticket for our Global Cosmetics Regulation Conference in London on April 25!
The one-day event will bring together our global experts and speakers from the cosmetic industry to cover a variety of topics and jurisdictions including the EU, UK, China, South Korea, and Turkey.
The?event?will?provide?you?with?plenty?of?opportunities?to?ask?questions and help you to stay up-to-date with regulatory obligations in the ever-changing regulatory?landscape. Find out more about registering by clicking the banner above.?
Chemical news
EU Proposes a Regulation on F-gas – Quota Allocation Subject to Payment
On March 1, 2023, members of the Committee on the Environment, Public Health and Food Safety (ENVI) adopted their opinions on amending the regulation on fluorinated greenhouse gases (F-gas) emissions with:
And the further target is to accelerate the transition to climate neutrality. The report is scheduled to be adopted during the March 29-30, 2023 plenary sitting and will constitute Parliament’s negotiating position with EU governments on the final shape of the legislation on F-gas. Find out more via the link below.
Have You Included a UFI Code in Your SDS when Exporting Mixtures to the EU?
Starting in 2023, the amendments to Annex II of REACH regulation on safety data sheets (SDSs) became mandatory. This means that related enterprises must affix a unique formula identifier (UFI) code in section 1.1 of their SDS when exporting mixtures to the EU. Mixtures that meet specific conditions must also complete poison center notification (PCN).
For those less familiar with the requirements, this article explains a bit more about UFIs and PCNs.
FREE WEBINAR: The Progress of K-REACH Regulation and Practical Experience Sharing
This webinar will introduce the progress of South Korea's K-REACH regulation and share our practical experiences on full registrations so that enterprises could take future registration projects in their stride.??
The webinar will take place today (March 15, at 14:00 GMT). You can still?register here?or via the link below.
FREE WEBINAR: Progress of Existing Chemical Substances Registration regulations in Taiwan and registration experience sharing
Taiwan's EPA issued the revised "Regulation of New and Existing Chemical Substance Registration" on?November 23, 2021. It extended the deadline for completing the registration of priority existing chemical substances (Pecs) designated in phase I.
Our technical team has served customers in completing hundreds of existing chemical substance registration projects. This webinar will provide professional regulatory interpretation, compliance advice, and share our experience with enterprises that are concerned about chemical substance management policies in Taiwan.
The webinar will take place on?March 29, at 14:00 GMT, register below.
Personal and home care product news
Health Canada Plans to Update the Cosmetic Ingredient Hotlist
On January 23, 2023, Health Canada issued a notice regarding updates to the Cosmetic Ingredient Hotlist. The modification mainly covered three parts, including:
To find out more, click the link below.
The Use of 1,4-dioxane or Mercury in Cosmetics and Personal Care Products is Prohibited in New York State
In December 2022, Hochul, governor of New York State, signed an amendment to the Environmental Protection Act (A8630A) to prohibit the use of 1,4-dioxane or mercury in cosmetics and personal care products.
The bill will come into effect on June 1, 2023, after that date, cosmetics or personal care products containing 1,4-dioxane or mercury must not be sold in New York State.
From December 31, 2022, the trace requirements of 1,4-dioxane are as follows:
From December 31, 2023, the trace limit of 1,4-dioxane will be reduced:
Find out more in the link below.
FREE WEBINAR: The Updated US Cosmetics Regulation (MoCRA) – What the Changes Mean for Industry
For many years, the state governments have largely driven US cosmetic regulatory changes. However, in?December 2022, the FDA introduced its first major update to the overarching cosmetic regulation in 84 years.
The update – referred to as the Modernization of Cosmetics Regulation Act (MoCRA) – aims to expand the FDA’s presence and jurisdiction in the US cosmetics market.
This webinar was rescheduled and will now take place tomorrow?(March 16, 14:00 EST).?Christopher Ketchum?will outline the major changes put forth by the MoCRA, highlight some important compliance deadlines, and present areas for consideration in the changing regulatory landscape.
Webinar registrants will gain access to a?free one-hour regulatory consultation?with a member of our team.?Register here?or find out more in the link below. If you are unable to attend the event, you will still be able to access the recording and slides after the event via the link below.
FREE WEBINAR SERIES: EU/UK Cosmetic Regulations
March 29, Overview of Cosmetic Regulations in the EU – in this webinar Yasmine Boulanouar will provide background on the EU cosmetic regulation. She will cover several of the key requirements including product information file (PIF), cosmetic product safety report (CPSR), Responsible Person, and Labelling. As well as compliance tips aimed at EU and non-EU cosmetic product companies.
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April 5, Latest Updates of Cosmetic Regulations in the UK – Yasmine Boulanouar will provide an introduction to updates to the UK cosmetic regulations. Yasmine will also compare the UK regulations with those in the EU. And she will provide compliance tips for UK and non-UK cosmetic product companies.
April 12, How to be a compliant Responsible Person for Cosmetic Products in the EU and the UK – in this webinar Bryan Zhou will cover the definitions of a Responsible Person. Bryan will also go into detail on how to be a compliant Responsible Person. And explain how non-EU/UK cosmetic companies should go about choosing a qualified Responsible Person.
April 19, Regulatory Requirements of Cosmetic Ingredients in the EU and the UK – in this webinar Julie Harrington will provide regulatory requirements from both the cosmetic and chemical regulations (including CLP and REACH). She will also provide compliance tips from CIRS.
Register for one or all of the webinars via the link below and gain access to a free one-hour regulatory clinic with a member of our team.
Food and food contact material (FCM) news
Latest Developments on the Safety Assessment of Microorganisms in EFSA – the Updating of QPS List
Recently, the European Food Safety Authority (EFSA) published the updated list of QPS-recommended microorganisms, in which six new taxonomic units (TUs) received the qualified presumption of safety (QPS) status, and one existing microorganism was withdrawn.
In China, the QPS list can be commonly found in the approval information of microorganisms from the announcement interpretation of “Three New Foods” issued by the national health commission (NHC). It is easy to become confused about what the QPS list is, and how it works in the compliance of microorganisms in China. Therefore this article covers the two questions mentioned above in three parts:
NHC Newly Approved One New Food Raw Material, 16 New Food Additives, and 11 Food-related Products
On March 2, the National Health Commission of the People's Republic of China (NHC) issued an announcement (No. 1 of 2023) for “Three New Foods” with 28 products approved, including:
Find out full details in the article below.
FAQs on Health Food Registration and Filing in China
We’ve translated a selection of some of the latest FAQs on?health food registration and filing?in China to help you understand the current requirements. The article covers answers to the following questions:
Q: Can health food currently be declared?
Q: What are the differences between health food registration and filing?
Q: What are the qualification requirements for applicants of health food filing?
Q: What are the qualification requirements for applicants of health food registration?
Q: Are foreign test reports on animal tests and human food trials valid in China?
Q: For health food sold on cross-border e-commerce platforms, how can overseas food manufacturers register with the General Administration of Customs, P.R. China (GACC)?
Free Webinar: Application Trend in China – Analysis of the Compliance Processes of Hot New Food Raw Materials and Additives such as NMN and HMOs
According to the requirements in the Food Safety Law of China, new food raw materials and additives used for food production must pass the safety assessment of the National Health Commission (NHC). In recent years, with the support of favorable policies, enterprises have made many innovations, which has promoted the emergence of various new raw materials seeking compliance with?relevant regulations.
This webinar aims to help enterprises gain an overview of the current food industry. On March 21, 14:00 GMT 沈洁 (Jessie Shen) will analyze the application approval of new food raw material and additives in China from 2018 to 2022, and share the latest information on the research and compliance progress of the trending food raw materials such as Human milk oligosaccharides (HMOs), nicotinamide mononucleotide (NMN), and postbiotics.
Longer reads
Ten New FSMP Products have been Approved for Use in February 2023 – Bringing the Total to 104 Approved Products
According to information recently released by the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) products approved in China has reached 104.
Companies must register FSMP products with the SAMR. This applies to both imported products as well as those produced domestically and marketed in China. Ten new FSMP Products have been approved for use in February 2023:
To see detailed information about all the FSMP products click the link below.
2018-2022: Summary of the Acceptance and Approval of New Food-Related Products (including Expanded Use) in China
What do you know about the acceptance and approval status of new food-related products (including those approved for expanded uses) in China between 2018 and 2022? In this article, our food experts will provide you with detailed information about the registration status of food-related products.
According to the statistics, 227 products have been accepted between 2018 and 2022, with:
To read the full analysis click the article below.
2018-2022: Summary of the Acceptance and Approval of New Food Raw Materials in China
What do you know about the acceptance and approval status of new food raw materials in China between 2018 and 2022?
In this article, our food expert will provide you with detailed information about the registration status of new food raw materials in China.
2018-2022: Summary of the Acceptance and Approval of New Food Additives (including Expanded Use) in China
Do you know the acceptance and approval status of new food additives in China between 2018 and 2022? In this article, our food experts team will guide you through detailed information about the approval status of new food additives in China.
According to the statistics, 301 new food additives were accepted between 2018 and 2022.
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