GPC Newsletter Sep-2021



Regulatory News

On the 6th of August, the National Medical Products Administration (NMPA) enacted “Measures for Cosmetics Supervision and Administration” which will come into force from the first day of 2022. This is the first regulation that focuses on cosmetic production and management in China, according to NMPA.

There are seven chapters and sixty-six articles which outline the license, manufacture, supervision, liability, and management rules, including the following: 

  • Certificate holders, agents and entrusted factories must establish a system that can guarantee the quality management process.
  • The storage spots are not allowed to store any products that might affect the quality of cosmetics.
  • Recording the sources of incoming raw materials and cosmetics to ensure that products are traceable. All the records are subjected to inspection.

In addition, the 5-years certificate validity period can be re-counted under certain circumstances, which lessen producers’ burden. The rules on children's cosmetics are stricter as a special label must be made on the children’s products.

For more inquires on cosmetic regulation in China, please contact compliance@gpcregulatory.com 

On the 26th of July, the National Health Commission of China (NHC) announced that 9 food additives and 19 food reactants were approved, according to China Food Safety Law.

The above mentioned 28 substances are the following:

9 food additives:

  • 4-α-glycosyltransferase
  • alpha-amylase
  • Polygalacturonase
  • Pectin esterase
  • Phosphoinositide Phospholipase C
  • Phospholipase C
  • Xylanase
  • Glucoamylase
  • Lipase

19 food-related reactants and new contacts

  • The reaction product of sodium silicate with trimethylchlorosilane and isopropanol
  • Dodecylguanidine hydrochloride
  • Poly-1,4-butanediol adipate
  • talcum powder
  • The reaction product of phosphorus trichloride with biphenyl and 2,4-di-tert-butylphenol
  • C.I. Solvent Red 135
  • C.I. Pigment Violet 15
  • Zinc phosphate (2:3)
  • Ethanolamine
  • 2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol
  • 2-methyl-2-acrylic acid-2-ethyl-2-[[(2-methyl-1-oxo-2-propenyl)oxy]methyl]-1,3-propanediol ester
  • Polymer of 2-acrylic acid and 2-ethylhexyl-2-acrylate
  • (E) Polymer of -2-butenedioic acid, 1,3-isobenzofurandione and tricyclodecane dimethanol
  • 1,4-phthalic acid and 1,3-phthalic acid, 2,2,4,4-tetramethyl-1,3-cyclobutanediol, 1,4-cyclohexanedimethanol and 1,6 -Hexanediol polymer
  • Polymer of 2-methyl-2-acrylic acid and N-(butoxymethyl)-2-acrylamide, styrene and ethyl 2-acrylate
  • 2,6-Dimethyl 2,6-naphthalenedicarboxylate and 1,4-cyclohexanedimethanol, 1,2-ethylene glycol, 2,2'-oxybis[ethanol] and β3, β3, β9 ,β9-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol polymer
  • Poly[imino-1,4-butanediylimino (1,10-dioxo-1,10-decanediyl)]
  • Polymers of 2-acrylic acid with 2-butyl acrylate, vinyl acetate, 2-ethylhexyl 2-acrylate and ethyl 2-acrylate
  • Esterification of 2,5-furandione and ethylene polymer and vinyl alcohol homopolymer

For more inquires about the application scope and limitations of the above-mentioned new contacts and additives, please contact compliance@gpcregulatory.com.

Last update: 2021-08-31

The Ministry of Environment (MoE) in South Korea added the provision to expand the definition of existing substances on Aug 12th, 2021.

According to K-REACH, existing substances are those listed in the inventory. The definition of existing substances has been expanded to include various forms of substances including: 

  • hydrate or anhydrous of existing substances
  • reaction products consisting of two or more existing substances
  • Isomers of an existing substance

It also includes those chemical substances mentioned in the attachment (in Korean)

This expansion is due to the definition of existing substances now includes existing chemicals' reaction products and isomers. Registrants are recommended to check if their substances are considered as existing substances after the expansion of the definitions under K-REACH. This update came into effect immediately.

South Korea enacted the Act on Risk Assessment of on July 27, 2021. This Act aims to protect and promote public health by evaluating risk assessment of products applied to the human body and regulating matters of safety management.

The Ministry of Food and Drug Safety (MFDS) will examine risk assessment of various products and channels to understand the overall impacts and risk factors of products applied to the human body. MFDS will also establish and implement a master plan on risk assessment of products applied to the human body every five years, following deliberation by the risk assessment policy committee, to manage risk assessment systematically and effectively.

Products applied to the human body include 11 categories as follows:

  • Foods, food additives, equipment, container and packaging defined in ˹Food Sanitation Act˼
  • Agricultural and marine products and processed foods defined in ˹Agricultural and Fishery Products Quality Control Act˼
  • Livestock defined in ˹Livestock Products Sanitary Control Act˼
  • Liquors defined in ˹Liquor Tax Act˼
  • Health Functional Foods defined in ˹Health Functional Foods Act˼
  • Medicine, herbal medicine, ingredients of herbal medicine and quasi-drugs defined in ˹Pharmaceutical Affairs Act˼
  • Narcotics defined in ˹Narcotics Control Act˼
  • Cosmetics defined in ˹Cosmetic Act˼
  • Medical Devices defined in ˹Medical Devices Act˼
  • Hygiene Products defined in ˹Hygiene Products Control Act˼
  • Other products controlled by the Minister of Food and Drug Safety based on Presidential Decree

This comes into effect from January 28th, 2022.

ECHA added new updates in the Guidance on Registration in August 2021. The new updated version of the guidance document offers advanced support to the companies with their registration obligations. 

The Guidance on Registration was first published in June 2007 and since then, it has been revised 9 times. The updated Guidance extends information on notification of a cease of manufacture or import and added a new section explaining when the registration of a substance is no longer valid.

Another important aspect is the alignment with the Guidance on data sharing. Joint submission of data was previously mentioned in the Guidance on data sharing, now ECHA added a section (Section 4.3) on joint submission.

Now, the guidance document is associated with two European Commission implementing regulations – one on the “registration and data sharing of phase-in substances” after the final registration deadline, and the other on “updates of registration dossiers”

The new version explains how the registration process will proceed as pre-registrations are no longer valid. It also suggests to companies how to calculate the tonnage band they are registered for. Also, this Guidance is helpful for the companies to decide when they need to update their REACH registrations.

For more inquiries, please contact compliance@gpcregulatory.com.   

ECHA elucidates the rules on accepting adaptations for degradation testing and requiring combined studies for mutagenicity. It also suggests companies should consider these changes while deciding whether to update their registrations. 

Chemical Safety Assessment does not permit registrants to exclude the standard information on degradation of the substance from column 1 under REACH (Annex IX, section 9.2., column 2). Instead, biotic degradation testing must be proposed by companies if the chemical safety assessment indicates the need to further investigate the degradation of the substance and its degradation products. The choice of the appropriate tests depends on the results of the chemical safety assessment 

For adaptation of the degradation tests listed in column 1, companies apply the specific rules for adaptation listed in REACH Annex IX, sections 9.2.1.2-4 and 9.2.3, column 2, along with the general rules for adaptations, listed in Annex XI. As explained in Annex IX and XI, exposure-based adaptations can also be considered when human/environmental exposure is absent or so low that additional hazard information will not lead to improved risk management. But the legal basis for such adaptation must be well-defined. Also, It has been suggested by ECHA that for all adaptations, sufficient justification and documentation are needed while considering the whole lifecycle of the substance. 

Furthermore, for mutagenicity studies, a combined comet assay and micronucleus test is required for the substances registered over one tonne per year under Annex VII and also for annexes VIII, IX and X. 

The combination study will be requested if there is: for mutagenic studies 

  • a positive Ames test – which checks the potential of chemicals to create mutations in bacteria. 
  • an indication of a chromosomal aberration concern; and 
  • no other adequate and appropriate in vivo genotoxicity data in the registration. 

This combined study can be helpful to lessen animal testing while providing useful information on the potential of a substance to induce chromosomal aberrations or gene mutation in vivo. 

On the 5th of  August, the Government of Canada nominated long-chain PFCAs, their salts and related compounds (also known as precursors) for consideration under the Stockholm Convention on Persistent Organic Pollutants (POPs). The Stockholm Convention is a multilateral treaty aimed at protecting human health and the environment by eliminating/restricting the global production and use of POP.s POPs are chemicals that: 

  • remain intact in the environment for a long period of time 
  • accumulate in living organisms 
  • are harmful to humans and/or to the environment 
  • have properties that cause them to travel long distances and become widely distributed throughout the environment 

Although long-chain PFCAs, their salts and related compounds have previously undergone a Canadian ecological screening assessment, the report concluded that long-chain PFCAs, their salts and their precursors are entering the environment at levels that are harmful to the environment. The manufacture, use, sale, offer for sale or import of long-chain PFCAs, their salts and precursors and products that contain them have been prohibited since 2016, under the Prohibition of Certain Toxic Substances Regulations, 2012 , with a limited number of exemptions. However, these substances have not been evaluated in Canada from a human health perspective. 

Human and animal toxicity data are not available for every long-chain PFCA, salt or related compound. However, considering that long-chain PFCAs have similar structures and substances with similar structures behave similarly in the body, all of these substances may be associated with similar health effects. 

Furthermore, a growing number of jurisdictions, including the United States, Australia and the European Union, are developing action plans to address the PFAS class of chemicals, including long-chain PFCAs. 

As per section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of Lotus corniculatus extract. This substance was identified as a priority for assessment, as it met the categorization criteria under subsection 73(1) of CEPA. Lotus corniculatus is a plant that is also known by the common name ‘bird's-foot trefoil’.  

The ecological risk of Lotus corniculatus extract was characterized using the ecological risk classification of organic substances (ERC), a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification.  

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from Lotus corniculatus extract. It is concluded that Lotus corniculatus extract does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity, concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. Also, the quantity does or may not constitute danger to the environment on which life depends. 

The general population of Canada may be exposed to Lotus corniculatus extract through the use of cosmetics, including body lotion and lip balm. 

The Government of Canada is accepting comments on the draft screening assessment for 60 days, until 13th October. 

 

 

The Ministry of Health, Turkey published on their webiste the draft regulation on the amendment of Turkish Biocidal Product Regulation.

 Current Biocidal regulation came into force on 31.12.2009 in Turkey. The regulation aims to assess the effects of biocidal products on humans, animals, and the environment while regulating the classification, labeling, packaging requirements, exports, licensing for biocidal products, and conditions for putting products into the market.  

To prevent confusion and to make regulation more practical, this draft is prepared to amend articles regarding application for license and registration and definition of the authorized laboratory. With this amendment, this regulation will be in line with European Union Biocidal Regulation. According to this amendment, pre-application is no longer needed, and the definition of the authorized laboratory has been changed. 

 Interested people can submit their opinion through an official form to hsgm.cevre@saglik.gov.tr by 10.09.2021.  

On July 24, Peru’s Ministry of the Environment (MINAM) published Decree 18/2021. By this Decree, Peru creates the Pollutant Release and Transfer Register (RETC by its acronym in Spanish).

The new database constitutes a new informational tool of potentially harmful chemical products and substances. The purpose is to facilitate public access to information on releases and transfers of pollutants while contributing to decision-making processes on environmental management.

Since the new regulation is broad in scope, different economical activities are required to comply. It includes, agriculture, mining, manufacture, suppliers, providers, transport, and storage facilities. A complete list of those who need to comply is displayed in Annex 1.

The report must include three parameters: chemical substances, their physicochemical characteristics, and total hazardous waste produced. Annex 2 give further details on such elements.

Altogether, the declaration content must have:

  • Company information, operations, and processes
  • Water and energy consumption
  • Emissions amount (air, water, and soil)
  • Sewage and waste amounts
  • Company’s environmental practices and certificates

Declarants have until March 31st of each year to report. The declaration must be made once a year through the RETC digital platform.

The Decree foresees a 3-year adaptation period becoming mandatory in July 2024. Companies can still report voluntarily until then. The Peruvian authorities published a guideline to assist in reporting.

The initiative is linked towards enhanced chemical management in Peru. The Ministerial Resolution 439/2020, which proposes the National Regulation and Control of Dangerous Substances and the GHS adoption underwent public comments in September 2020. This may indicate a new version coming to light in 2021.

 

On 31st August 2021, the United Kingdom’s Health and Safety Executive (HSE), in charge of implementing UK REACH, published a draft recommendation for the inclusion of two substances into the Authorization List: Dicyclohexyl phthalate (CAS 84-61-7) and Disodium octaborate (CAS 12008-41-2). These substances that were found to have reprotoxic properties, are part of the seven substances previously proposed by ECHA for inclusion in the EU Authorisation list. The other five substances were not selected by HSE for inclusion in the UK Authorisation List, thus showing a significant divergence from ECHA. 

This move raises questions about HSE’s capacity to assess substances and handle applications at the same pace as ECHA. It is also a source of concern both for the industry, for whom regulatory divergences will lead to increased costs, and for NGOs who fear that the UK may not be able to keep up with the EU’s level of chemical safety.

The 27th October 2021 deadline for submitting a Downstream User Import Notification is approaching fast.  

As a reminder, your substances are eligible for DUIN if: 

  1. They are registered under EU REACH; and  
  2. They were placed on the GB market between 1st January 2019, and 31st December 2020. 

Once your substances have been notified via DUIN, you may continue to place them on the GB-market, while postponing the registration deadline by 2, 4 or 6 years (depending on the substances’ tonnage band and hazard profile). 

Past 27th October 2021, DUIN will not be applicable anymore. This means that, to place your substances into the GB, you will first need to fully register your substances under UK REACH before you may place them on the GB market.  

As a non-GB substance manufacturer, you may not submit the DUIN yourself. Instead, you should either:  

  • Let your GB-based importer submit the DUIN; or 
  • Appoint a GB-based Only Representative to submit the DUIN on your behalf.   

Via our London office, GPC (UK) may gladly assist you as your GB-based Only Representative to meet your DUIN requirements within the above deadline! 

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