CIRS Group regulatory news 03 – September 2022
Welcome to the third edition of the regulatory newsletter from the CIRS Group. You can also see all our updates as they're published by?following?our LinkedIn page.
We are delighted to announce that on August 31, our South Korean branch registered as an environmental consulting company under the Environmental Technology and Industry Support Act. This means we may receive preferential access to information. We are happy that four years after its establishment CIRS?Korea has become one of the top regulatory compliance consulting companies in South Korea.
Are your cosmetics compliant for use in China?
There has been a lot of change in the Chinese cosmetics industry since the new overarching regulation – Cosmetics Supervision Administration Regulation (CSAR) – came into force on January 1, 2021.
To help you keep up-to-date and compliant we have prepared this infographic of the upcoming deadlines.
On October 25, we will also be hosting a free webinar that will explore the process of importing some of the most popular finished cosmetic products for the EU and US into the Chinese market. It will cover the journey from beginning to end, touching on some of the challenges as well as the practicalities such as labeling requirements and upcoming deadlines.
The speakers – Julie Harrington from the EU office and Christopher Ketchum from the US office – will also be able to provide some practical tips and insights from a European and American perspective.
Chemical news
New rules for hazardous chemicals in Shangdong from October 30
The Department of Emergency Management of Shandong Province will begin implementing the “One Enterprise, One Product, One Code” management rules. After its implementation, every hazardous chemical manufactured and imported by enterprises in Shandong Province will need to include a safety information code (a unique QR code), which contains safety information. This is to provide support in the supervision of hazardous chemicals and efficient transmission of information on hazardous chemicals.
If you manufacture or import hazardous chemicals in Shangdong make sure you have updated your information via the integrated service system for the registration of hazardous chemicals by September 30.
The code is automatically generated after the information submitted via the system has been approved. Enterprises manufacturing or importing hazardous chemicals must place the safety information code on the packaging (or outer packaging) of hazardous chemicals, or on the blank labels before October 30. Downstream users and relevant personnel such as regulatory authorities and emergency rescue teams can acquire safety information on chemicals by scanning the QR code.
To find out more information click here or the link below.
Revised K-REACH exemption rules will benefit low-volume new chemical substances
On August 1, South Korea published revised K-REACH exemption rules, which mean that enterprises manufacturing/importing new chemical substances for R&D use in volumes of below 0.1 t/y no longer need to provide confidential business information (CBI).
Previously, they were required to provide authorities with detailed information, including the specific name and CAS number of the substance when applying for R&D exemptions.
However, these can now be exempted from K-REACH registration but companies still need to submit an application for exemption. These revised rules bring benefits to R&D and chemical reagent enterprises by protecting their CBI. You can find more information here.
Shanghai Customs is cracking down on illegal hazardous chemical imports
Shanghai is the world's busiest port and one of the largest for the import and export of hazardous chemicals. Therefore the Customs department attaches great importance to the safety of these chemicals. According to a notice published by Shanghai Customs, it seized 3,025 tons of illegal hazardous chemicals between January and July of 2022. You can find out more here or in the link below.
See our FAQs for more information on hazardous chemicals in China.
UK's HSE seeks comments on an authorization request
The UK's Health and Safety Executive (HSE) has received a request for authorization for two substances for use in ten in vitro diagnostic (IVD) assays for clinical chemistry and drug monitoring products.
The substances are:
As a result, the HSE is asking for scientific and technological information on alternatives or processes of the substances. The deadline for comments is October 4.
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More information is available here.
China's MEE consulting on the proposal to add six substances to the IECSC
China's Ministry of Ecology and Environment (MEE) is consulting until September 14, on the proposal to add six substances to the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). You can see the full list here.
If a substance is not included in the inventory, new chemical substance registration must be carried out in accordance with MEE Order 12. For more information, please click?here.
We have prepared a full list of the updates to the IECSC since its publication in 2013, or you can use?our free?Asia Pacific Chemical Inventory Search System?(APCISS) to search and see if your substance is listed in the IECSC.
Food and food contact material (FCM) news
China's NHC approves one new food enzyme and expands the scope for two food additives
On September 7, the National Health Commission of the People's Republic of China (NHC) approved one new food enzyme and expanded the scope for two existing food additives.
Namely:
More information is available here or via the link below.
China approves six new FCMs and expands the use of two others
On September 8, the NHC also approved six new food contact materials (FCMs) and expanded the scope of use for a further two FCMs.
For full details of the newly approved FCMs click here or the link below.
Longer reads
Confused by hazardous chemicals rules in China? Check out our FAQS
The formulation of management regulations for hazardous chemicals in China is very complicated because several different departments and regulations are involved.?We have put together this article of frequently asked questions to try and assist you in navigating the complexities.
Events
Julie Harrington from the EU office will be presenting at the Cosmetorium 2022 at the Palau de Congressos in Barcelona on September 28.
Her presentation will cover how to successfully register a cosmetic ingredient on China's NMPA safety information platform before the relevant deadlines. She will also share some practical advice and tips from her own experience with the regulation to date.
Xiang Li will also be manning our stand (no. 107) at the event, come and say hi if you're attending. You can find out more about the event here.