GPC Newsletter Sep-2022


Regulatory News

On 17 august 2022, the government of Canada (published in the Canada Gazette) issued notification requirements for some new uses of the paint additive calcium 2-ethyl hexanoate.

In 2018, Canada came to the conclusion that while the chemical is not toxic at the current levels of exposure, its possible developmental effects make it potentially dangerous for human health if its use increases. It was therefore suggested to impose a Significant New Activity (SNAc) provision of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to enable the government to evaluate the risk of certain new uses prior to their approval in Canada.

As published in the Canada Gazette on 17 August 2022, SNAc should be notified if calcium 2-ethylhexonate is used in cosmetics or consumer products above 0.1 % by weight. Paints and coatings that dry as a solid film and have a concentration under 0.5 % by weight are exceptions. Import of more than 10 kg per year for such uses should submit a Significant New Activity notice (SNAn).

Calcium 2-ethyl hexanoate was evaluated along with 2-ethylhexyl 2-ethylhexanoate under the Chemicals Management Plans (CMP).

 

If you have further queries regarding Canadian Regulations, please contact GPC via compliance@gpcregulatory.com. For more information regarding our services kindly visit our site https://www.gpcgateway.com.

 

Under Annex VIII to the CLP Regulation, importers and downstream users placing hazardous mixtures on the EU market are to provide specific information on their mixtures to appointed bodies. The platform for submission is called “Poison Center Notifications” (PCN), and companies dealing with certain hazardous chemicals and mixtures are obligated to report and provide information to it. On 31 August 2022 it was announced that Iceland has joined ECHA’s submission portal and from now on would accept PCN submissions through ECHA’s submission portal. It is expected that Bulgaria and Slovakia would join the ECHA’s submission portal. Currently, both countries remain unconnected to ECHA’s submission system. However, it is reported that both counties are in process of working through the onboarding procedure. 

 
 

The Original information regarding Iceland joining ECHA could be found on the following link: 

https://echa.europa.eu/view-article/-/journal_content/title/9109026-208 

  

More information regarding PCN and ECHA could be found on the following link: 

https://poisoncentres.echa.europa.eu/about-us 

The European Union’s Committee for the REACH Regulation will discuss a restriction proposal on microplastics by the European Commission in its upcoming meeting on September 23, 2022.


The release of microplastics – “synthetic polymer microparticles” in the restriction proposal – is a key environmental concern due to their pervasiveness and their lack of biodegradability. Microplastics may end up in the environment through the use of bigger plastic products (a phenomenon known as unintentional release of microplastics) or might be intentionally added to a range of products. 


The current REACH restriction proposal by the European Commission is one of the deliverables under the EU’s Circular Economy Action Plan adopted in 2020. It focuses on tackling intentionally added microplastics by forbidding their placement in the market (be it on their own or as an intentional addition in mixtures).


Natural, degradable and soluble polymers are excluded from the restriction, which includes references to the relevant tests with which biodegradability can be demonstrated. Beyond these exemptions, the use of microplastics will still be allowed for use at industrial sites and for several product categories (such as for instance medicinal products for humans and animals, fertilizing products, or food additives). The proposal includes labelling and reporting provisions for many of the exempted products. 


For some of the product groups within the scope of the restriction proposal, the Commission is proposing phase-in deadlines for the prohibition of placement in the market. For those groups, said prohibition of placing intentionally added microplastics in the market would apply as detailed in the table below. 

 

Date from which the prohibition applies

Product groups

4 years after the entry into force of the restriction

Rinse-off cosmetics

5 years after the entry into force of the restriction

Detergents, fertilizing products, and horticultural products other than plant protection products

6 years after the entry into force of the restriction

Granular infill for use on synthetic sports surfaces, polymers used in the encapsulation of fragrances, leave-on cosmetic products, and medical devices

8 years after the entry into force of the restriction

Plant protection products and biocidal products

12 years after the entry into force of the restriction

Make-up and leave-on lip and nail cosmetic products

 

Stating from 8 years after the entry into force of the restriction, these products must include the following statement in the label: “This product contains microplastics”

 

REACH restrictions are adopted through a procedure known as “regulatory procedure with scrutiny”. In it, the European Commission needs to secure the favorable opinion of the REACH Committee. Furthermore, for the three months after the Committee’s opinion, both the European Parliament and the European Commission can object to the proposed measure. If no such objection is raised, the Commission proposal is incorporated into Annex XVII of the REACH Regulation and becomes law.

Expert committees for the Rotterdam and Stockholm conventions will hold meetings in the upcoming weeks. At the meetings, aspects relative to trade requirements for hazardous pesticides and chemicals, and regulatory action on persistent organic pollutants (POPs) will be discussed. 

 

The 18th session of the Rotterdam Convention’s Chemical Review Committee will be held in Rome from 19 to 23 September. The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade focuses on information exchange on the restrictive measures taken by parties to the convention. Its Committee discusses whether substances in which parties are taking action should be added to the Convention’s Annex III, which requires that other parties express whether they would like to ban, permit or attach conditions to the import of such substance. 

 

At its 18th meeting, the Chemical Review Committee  will discuss guidance documents (the basis for  for the following two chemicals: 

  • iprodione
  • terbufos 

Additionally, it will review the regulatory action notified by several parties on the following chemicals: 

  • amitrole
  • carbaryl
  • carbon tetrachloride
  • chlorfenvinphos
  • methidathion
  • methyl bromide
  • methyl parathion
  • mirex
  • paraquat 
  • thiodicarb

 

The Stockholm Convention POPs Review Committee will also hold its meeting between 26 and 30 September in Rome. The Stockholm Convention on Persistent Organic Pollutants (POPs) seeks to mitigate the impacts of said chemicals on human health and the environment. It does so by listing specific POPs in its different Annexes for Prohibition, Restrictions, or measures to reduce their impact. 

 

The POPs review Committee evaluates proposals by parties to classify substances as POPs and take regulatory action on them. It develops risks profiles for the substances to determine whether global action is needed, evaluates risk management measures, and proposes specific action to be taken under the Convention. 

 

In its 18th meeting, the POPs Review Committee will consider risk management for the chemicals Dechlorane Plus and UV-328. It will also consider risk profiles for chlorpyrifos, chlorinated paraffins with carbon chain lengths in the range C14-17 and chlorination levels at or exceeding 45 per cent chlorine by weight, and long-chain perfluorocarboxylic acids (LC-PFCAs), their salts and related compounds. 

 

The Committee will also consider proposals for exemptions for decabromodiphenyl ether and short-chain chlorinated paraffins, and alternatives to perfluorooctane sulfonic acid, its salts, and perfluorooctane sulfonyl.

 

While not directly applicable, the decisions taken under the Rotterdam and Stockholm conventions are incorporated into national law (in the EU, through Regulations (EU) 649/2012, concerning the export and import of hazardous chemicals, and (EU) 2019/1021, on persistent organic pollutants). 

On September 8, 2022, the European Commission adopted a delegated act under Regulation (EU) 2019/1021, on persistent organic pollutants (the POP Regulation), clarifying the acceptable limits for the unintentional presence of hexachlorobenzene. 

 

Hexachlorobenzene is a Persistent Organic Pollutant banned under the 2001 Stockholm Convention on Persistent Organic Pollutants. In the European Union, the ban is implemented through Regulation (EU) 2019/1021, on persistent organic pollutants (the POP Regulation). The POP Regulation consolidated the older Regulation (EC) 850/2004 and its amendments into one single Regulation. It Annex I contains prohibited POPs, and includes – but is not limited to – POPs listed under the Stockholm Convention. Substances included in Annex I can not be placed in the market or used except under the conditions specified in the same Annex. 

 

The prohibition of placing Annex I POPs in the market does not apply to POPs that can be found in substances, mixtures or articles as unintended trace contaminants. Typically, Annex I includes a specific limit value for what constitutes an acceptable unintended trace contaminant. However, some listed POPs do not have this specification, creating uncertainty over the acceptable amount of contamination. 

 

Under the POP Regulation the European Commission is empowered to adopt delegated acts to align the system to the evolution of the Stockholm Convention and to account for scientific and technological progress. Now, it is adopting a Delegated Regulation amending the Annex I entry for hexachlorobenzene to establish a specific unintentional trace contaminant limit of 0.001% by weight (10 mg/kg). 

 

Similar delegated regulations have been adopted to establish or modify trace contaminant limits for PFOA, its salts and related compounds, and pentachlorophenol and its salts and esters. 

 

Under the POP Regulation, delegated acts become law 2 months after their adoption by the Commission unless the European Parliament or the Council of the EU explicitly oppose them. Said two-month period will be fulfilled on November 8, 2022. 

 

The Chemicals and Biotechnology Committee of the Organisation for Economic Co-operation and Development (OECD) adopted on September 2, 2022, a working document on the application of the “Safe and Sustainable by Design” (SSbD) concept to nanomaterials. These working descriptions – as the document is called – will be used in the further work of the OECD Working Party on Manufactured Nanomaterials, a body of the Chemicals Committee. Most notably, the work of the Working Party on nanomaterials includes: 

  • Supporting innovation to ensure that nanomaterials and advanced materials are developed in a safe and sustainable way supported by a circular economy.
  • Supporting a process for identifying and prioritizing the elements to be considered for safety and sustainability.

 

The document outlines working definitions for the key concepts of sustainability and SSbD. For the OECD Chemicals Committee, environmental sustainability entails remaining within the planetary boundaries and using green and sustainable chemistry principles to minimize the environmental footprint of chemical products. Socio-economically, the beneficial social impact and contribution to growth and innovation of products has to be ensured.

 

As for SSbD, its application to nanotechnology can be summarized in three pillars: 

  • Safe and sustainable products, which can be achieved by minimizing hazards and potential environmental issues at the design stage 
  • Safe and sustainable production, which relates to occupational and process safety and environmental preservation aspects (for instance, resource consumption and occupational health and safety).
  • Safe and sustainable use and end of life, which must be aligned with the circular economy and the waste hierarchy.

 

Discussions on a SSbD concept to guide policy discussions have been ongoing in several organizations after the European Commission included the concept in its Chemicals Strategy for Sustainability, published in October 2020. As a result of the Strategy, the Commission has been undertaking a far-reaching reform of its chemicals legislation and policy framework, including a development of the SSbD framework for research purposes. You can learn more about the SSbD concept and the Chemicals Strategy for Sustainability through our webinar on the topic. 
 

On 20 September 2022 the European Commission published a Draft delegated regulation introducing new hazard classes to the system established in Regulation (EC) 1272/2008, on the classification, labelling and packaging of substances and mixtures (the CLP Regulation). 

 

The CLP Regulation implements the UN Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) in the European Union. It is a key piece of legislation, given that general chemicals legislation and product-specific legislation often refer to it when establishing compliance obligations. 

 

Now, the Commission is proposing the introduction of new hazard categories that would go beyond the most recent revision of the UN GHS (Revision 9, adopted in 2021). The introduction of new hazard categories had been signaled by the Commission in recent years. For instance, the European Green Deal (2019) suggests to take into account scientific evidence on endocrine disruptors and persistent chemicals. Furthermore, the EU Chemicals Strategy for Sustainability, adopted in 2020, also calls new hazard classes and criteria addressing environmental toxicity, persistency, mobility and bioaccumulation. 

 

The Draft regulation would introduce the following new hazard classes and categories: 

  • Endocrine disruptors for human health, category 1 (known or presumed) and category 2 (suspected) 
  • Endocrine disruptors for the environment, category 1 (known or presumed) and category2 (suspected) 
  • Persistent, bioaccumulative and toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB) substances 
  • Persistent, Mobile and Toxic (PMT) or Very Persistent, Very Mobile (vPvM) substances 

 

The regulation includes the classification criteria for substances and mixtures, as well as the relevant labelling elements, including new hazard statements.  For PBT/vPvB substances, common criteria are established for persistence and bioaccumulation. However, given their difference in toxicity, they remain different categories. The same situation applies to PMT/vPvM substances. 

 

The new classification and labelling requirements would apply to substances 18 months after the regulation’s entry into force. In the case of mixtures, the transitional period would be 36 months. However, the draft establishes grace periods for substances and mixtures labelled before the entry into force and placed on the market before the end of the transitional period. The old classifications may continue to apply for 42 months for substances and 60 months for mixtures. 

 

While still a draft, the introduction of new hazard classes and categories in the CLP Regulation is a key development in chemicals management worldwide. As many countries around the world seek to adopt both the GHS and REACH-like regulations, this development opens space for divergence between the global and EU frameworks. Additionally, it is related to the upcoming revision of EU Regulation 1907/2006 (the REACH Regulation), as the Chemicals Strategy for Sustainability pointed to the categorization of endocrine disruptors, PMT and vPvM substances as substances of very high concern (SVHC) under REACH. 

 

In addition to these developments through delegated regulations, further changes to chemicals management in Europe are expected in the coming months, when the European Commission proposes amendments to the REACH and CLP Regulations themselves. 

 

Once adopted by the Commission, delegated acts enter into force automatically unless the European Parliament or the Council of the EU explicitly oppose them. The current draft is open for public comments until October 18, 2022. 


 

On 7 September 2022, the European Chemicals Agency (ECHA) published a call for comments on nine proposals to identify new Substances of Very High Concern (SVHC). SVHCs are substances that can have serious and often irreversible effects on human health and the environment. A substance that is identified as an SVHC will be added to the Candidate List for eventual addition to the Authorisation list. As of 10 June 2022, the Candidate list has 224 entries, some are groups of chemicals, so the overall number of impacted chemicals is higher. The Authorisation list has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants authorisation for continued use. 

The identification of SVHCs is based on the hazard properties of a substance. All interested parties are invited to submit comments during the consultation which lasts until 17 October 2022. Comments are particularly welcome on: 

  • The identity of the substance (i.e. on the substance name/EC number/CAS number/molecular structure etc.) 

  • Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) properties and on other properties that give rise to equivalent levels of concern. 

 

The nine proposals that the ECHA is looking for comments on are: 

  • 4,4'-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). Used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals. 

  • Perfluoroheptanoic acid and its salts (EC -, CAS -). The substances are not registered under REACH. 

  • Melamine (EC 203-615-4, CAS 108-78-1). Used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals. 

  • Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). Used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners. 

  • Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (EC -, CAS -). Used as a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives. 

  • Barium diboron tetraoxide (EC 237-222-4, CAS 13701-59-2). Used in paints and coatings. 

  • Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine (FC-770) (EC 473-390-7, CAS -). Used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing. 

  • 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA) (EC 201-236-9, CAS 79-94-7). Used as a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles. 

  • 1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] (EC 253-692-3, CAS 37853-59-1). The substance is not registered under REACH. 

The UK Health and Safety Executive (HSE), as the implementing agency for UK REACH, is currently consulting on different potential options for a UK REACH restriction on substances to be used in tattoo inks and permanent make-up. 


The proposed restriction would be in line with a similar restriction introduced in the EU through Commission Regulation (EU) 2020/2081, which entered into force in January 2022. 


According to the HSE, uncertainties about the substances causing tattoo-related complications and their prevalence, it is difficult to quantify the level of risk that is associated with substance use for tattoo inks and permanent make-up. The restriction is therefore proposed on a precautionary basis, and it seeks to address the lack of UK regulations on the topic. 


In line with the existing EU restriction, the UK restriction proposal would address the following groups of substances, imposing conditions on their use in tattoo inks and permanent make-up: 

  • Substances that have a harmonized hazard classification under the UK CLP for one of the following hazards: 
    • Carcinogenic, mutagenic, or toxic to reproduction (categories 1A, 1B or 2) 
    • Skin sensitising (categories 1, 1A or 1B) 
    • Skin irritant or corrosive (categories 1A, 1B, 1C or 2) 
    • Eye damaging and irritant (categories 1 or 2) 
  • Substances that have been prohibited under the EU Cosmetics Regulation (listed in Annex II therein) 
  • Colorants subject to use conditions under the EU Cosmetics Regulation (as specified in its Annex IV)

 

For these substance groups, HSE is proposing three alternative restriction options. While the restriction proposal contains several exceptions, the overarching approaches are depicted in the table below. A further point of differentiation is the automatic implementation of changes to the EU Regulation.
 

Substance group Option 1 Option 2 Option 3
Harmonized through UK CLP  Concentration limits Concentration limits  Concentration limits
Annex II of the EU Cosmetics Regulation

Cannot be used if prohibited 

Concentration limits  Concentr
Annex IV of the EU Cosmetics Regulation  Cannot be used if prohibited  Concentration limits  Concentration limits 
Automatic incorporation of list updates Yes for all

Yes for UK CLP

No for EU Regulation Annexes

Yes for all

 

Additionally, the restriction would also introduce some labelling requirements to complement existing regulations on the topic: 

  • The labelling of all ingredients that would not be identified under the UK CLP 
  • The highlight of the presence of nickel and chromium VI if applicable 
  • The provision of a manufacturer’s reference number
  • The identification of the intended use of a mixture as tattoo ink or in permanent make-up, and instructions for use 

 

Consultation on the scope of the restriction and on the proposed restriction options is open until November 6, 2022. An additional consultation will be held at a later stage on the socioeconomic impacts of the restriction. 
 

Ukrainian Ministry of Health has published a draft proposal to ban the chemical triclosan in production of plastic and food contact materials. Triclosan is an anti-bacterial chemical commonly used in kitchenware. The draft proposal suggests that a transitional period: all products containing triclosan put into circulation before 1st January 2023 are allowed to be on the market until 1st January 2024. The draft regulation is open for public commentaries until 17th of September. If the document will be approved, it will come into force three months after its official publication. 

The aim of this draft proposal is to bring safety requirements for FCMs closer to the compliance requirements of the European Union.  

Furthermore, Ukrainian Ministry of Health proposes new limitations on lead and cadmium in FCMs made of ceramic. The order, however, includes that ceramics put into circulation before the order comes into force, can stay in circulation. 

The new limitations are demonstrated in the table below: 

 

Cadmium 

Lead 

Flat and shallow articles 

0.8mg/dm 

0.07mg/dm 

All other articles that are fillable 

4.0mg/l 

 0.3mg/l 

Containers for packaging and storage that have a capacity of more than three litres 

1.5mg/l 

0.1mg/l 

If the proposal will get approved, the expected date of its entry into force is 6 months. 

On March 17th 2022, the SME regulation has been updated to redefine the micro, small and medium enterprises to match the value change of the Turkish Lira in the past years. The new definitions might affect companies who have declared themselves as SMEs before, subsequently affecting the official fees related to their business size for KKDIK registration.

With the registrations going forward to meet the deadline of December 2023 under KKDIK, the Ministry of Environment, Urbanization and Climate Change of Turkey is asking for a signed SME declaration from the registrants if they have previously declared themselves as SMEs.

You could find the new criteria under SME regulation here: 

 

Criteria set by SME Regulation of Turkey 

    Year 

 

    2022

Large Size 

Medium Size 

Small Size 

         Micro Size 

Head Count > 250 

Annual Net Revenue or Financial Balance

> 250 million ₺ 

Head Count < 250 

Annual Net Revenue or Financial Balance

250 million ₺ 

Head Count < 50 

Annual Net Revenue or Financial Balance

≤ 50 million ₺ 

Head Count < 10 

Annual Net Revenue or Financial Balance

≤ 5 Million ₺ 

 
It is important to check with the new definitions to see if the previous definitions are still met by the company.  As a result, you could complete your fee payments in accordance with the size of the company during the KKDIK registration process.    
 

The Ministry of Environment, Urbanization, and Climate Change of Turkey had the guidance documents published by the European Chemicals Agency translated for the ongoing KKDIK registration process and presented them to the chemical industry for their knowledge.

 

ECHA (European Chemicals Agency) had prepared guidance documents for the EU REACH registration process before, which are helpful to countries under registration processes. These guidance documents contain regulatory and facilitating information on many activities related to chemicals. Industry managers, chemical assessment experts, and personnel involved in data entry into the chemical registry system would benefit from translated guidance documents and instructions since these contain a lot of the data needed for the chemical registration system.

 

Since the deadline for registrations, December 2023 is approaching under KKDIK, it will be beneficial for the concerned people to examine the guidance documents on the chemicals help desk.

 

The Ministry would like to make sure that the registration of substances related to chemicals is made without delay by making use of the guidance documents for the completeness checks of these registrations can be carried out by them.

 

We recommend for those working in the chemical industry take advantage of the available resources and complete their registration processes at the earliest time.  

 

If you want to learn more about this, and the document, please contact GPC.

 

On 31 August 2022 a regulation entitled “Food Safety and Standards (Packaging) Second Amendment Regulations, 2022.” was published and enforced by The Food Safety and Standards Authority of India (FSSAI).

This regulation sets migration limits for antimony and Phthalic acid, bis (2- ethylhexyl) ester (DEHP) in food contact materials. As a result of this amendment, the list of specified substances with migration values from plastic materials intended for contact with food now contains nine substances. The migration limit value for antimony is 0.04 mg/kg and 1.5 mg/kg for DEHP.

The seven substances for which migration limit values were previously established in the “Food Safety and Standards (Packaging) Regulations, 2018” are as follows:

 

l. No.

Substance name

Migration limit value (mg/kg)

1

Barium

1.0

2

Cobalt

0.05

3

Copper

5.0

4

Iron

48.0

5

Lithium

0.6

6

Manganese

0.6

7

Zinc

25.0

State Administration for Market Regulation of China (SAMR) and National Standardization Administration of China (NSA) issued the final version of national skin disinfection standard – General Requirements for Skin Disinfectant GB 27951-2021. This standard will enter into force from 1st November 2022. After entering into force, it will replace the previous standard of GB 27951-2011 Hygiene requirements for skin disinfectants and will be under the supervision of National Health Commission of China (NHC). 

The main change in this new standard is that it sets new limits on heavy metals used in the disinfection. 

  • 10mg per litre (L) or kilogram (kg) for lead;  
  • 1mg/L or kg for mercury; and  
  • 2mg/L or kg for arsenic.  

In addition, it also specified several terms definitions, such as skin conditions, revised testing requirements for microbials, toxins and heavy metals in finished products, active ingredients etc. It will be clearer for companies to understand new toxicological testing requirements and limitations for heavy metals. 

For more information relating to China chemical and cosmetic regulation, please contact GPC via compliance@gpcregulatory.cn or follow our WeChat account at 46 0708381983. 

On 2nd Sep. 2022, National Institutes for Food and Drug Control of China (NIFDC) published a notification calling for public and indutry opinions on draft new China Cosmetic Safety and Techinical Standards (CSTS) which was made in 2022. 

The current CSTS was in force since 2015. In 2021, the new Cosmetic Supervision and Administration Regulation (CASR) was published. To keep cosmetic standards in line with the latest regulation requirements and the overarching aim of cosmetic regulation, CSTS (2015 version) was modified. The main modifications are the followings: 

  • List of limited cosmetic raw ingredients 

Based on the list of forbidden cosmetic raw ingredient, the definition of certain terms in list of limited ingredient and scope of list of limited ingredients have been modified in accordance with CSAR (2021). 

  • List of allowed raw ingredients 

Adding Lauroyl arginine ethyl ester hydrochloride as allowed ingredients and deleting Mercury-containing preservatives from this list. 

  • Test 

12 new test methods have been added, among which eight of them are toxicological tests and four of them are physical chemical tests. In addition, there 15 physical chemical tests have been modified and two toxicological tests have been modified. 

 

For more information relating to China cosmetic compliance activities, please contact GPC at compliance@gpcregulatory.cn

The Ministry of Food and Drug Safety (MFDS) in South Korea consults on a draft amendment of ‘Regulation on Safety Standards of Cosmetics’ under the Cosmetic Act on September 5th, 2022. This is to strengthen the safety management of cosmetics and protect public health by regulating some raw materials that may not be used or restricted to use in cosmetics.

 

The main updates include:

  • Remove some raw materials of hair dye from the restricted list and add it banned list

 

If you have any opinion on this amendment, please write your opinion and submit it to the MFDS.

The deadline for this consultation is Sep 19th, 2022.

The Ministry of Environment (MoE) in South Korea provides a guide to implement biocide management system for manufacturers and importers of consumer chemical products subject to safety verification. Under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), manufacturers and importers of biocidal substances and biocidal products must get approval from the MoE (The National Institute of Environmental Research (NIER)).

Scope of the biocidal products are as following:

  • 10 biocidal product types: sterilizers, algicides, antibacterial disinfectants for cleaning humidifiers, disinfectants to prevent infectious disease, repellents, insecticides for public health, repellents for public health, insecticides to prevent infectious disease, rodenticides to prevent infectious disease, and wood preservatives
  • Products whose main purpose is a biocidal function

 

Deadlines are as following:

  • Biocidal products (except for wood preservatives)

-Biocidal products containing biocidal substances approved within 2022: 2024.12.31

-Biocidal products containing biocidal substances not approved within 2022: 2023.12.31

  • Wood preservatives

-Biocidal products containing biocidal substances approved within 2024: 2026.12.31

-Biocidal products containing biocidal substances not approved within 2024: 2025.12.31

 

Approval of biocidal substances can take more than 1 year and 9 months for evaluation (excluding data revision and supplementation period), and approval of biocidal products can take more than 1 year and 3 months for evaluation (excluding data revision and supplementation period).

As it takes so long time for the evaluation, it should be taken into consideration to get approval within the deadline. In case of non-approval, manufacturing, import, sale, and distribution after the above deadline are prohibited.

The Ministry of Environment (MoE) in South Korea updates the ‘Regulations on Emissions Survey and Calculation Factors of Chemical Substances’ under the Chemical Substances Control Act.

The scope for emission survey is based on the Annex 1, which is categorized according to the Korea Standard of Industry Classification. For point pollution sources, the facilities subject to the emission survey are the ones with the permission to have emission facilities, but it can be exempted based on substance category and tonnage band. Also, nonpoint pollution sources can be included for the emission survey if necessary.

The chemical substances subject to emission survey are listed in Annex 2, and it should fall under any of the followings:

  1. Chemical substances and products produced at facilities
  2. Raw materials and additives used at facilities
  3. Process auxiliary substances used at facilities
  4. Chemical substances kept and stored at facilities
  5. Wastes processed at waste treatment plants
  6. Chemical substances used in other facilities (for example, chemical substances used for wastewater treatment, and maintenance and repair of facilities and equipment)

The validity of this regulation will be reviewed every three years from January 1, 2023.

The amendment came into effect immediately.

The Hazardous Substance Act B.E. 2535 was issued in 1992 and is the most important chemical control law in Thailand. The purpose of this Act is to regulate the importation, production, marketing, and possession of all hazardous chemicals (including industrial chemicals, pesticides and biocides) used in Thailand. The Department of Agriculture (DOA) takes responsibility for the control of fertilizer products for manufacturing, sale, importation, exportation, and transit.  

In Thailand, adjuvants and soil amendments do not require registration as these are not classified as fertilizers or as hazardous substances according to the Hazardous Substance Act. Adjuvants and Soil amendments are currently regulated under the Consumer Protection Act B.E. 2522 and amendment (No. 2) B.E. 2541.  

The Consumer Protection Act prescribes the requirements of adjuvant and soil amendment products. In order to protect consumer rights, it is important to designate adjuvants and soil amendments as label-controlled products. Thus, it is important to have appropriate elements and information on the product label as provided by the Notification. This Notification shall come into force after completion of four months from the date of its publication in the Government Gazette. 

If you have further quires regarding Thai Regulations please contact GPC via compliance@gpcregulatory.com. For more information regarding our services kindly visit our site https://www.gpcgateway.com

On 1 June 2022 the Thailand Ministry of Public Health (MOPH) published a notification regarding Quality or Standard of Plastic Containers in the Royal Gazette. The notification was previously announced in G/SPS/N/THA/484 on 27 January 2022. The notification has been effective since the day after its publication in the Government Gazette which was 18 June 2022 and the previous Notification (No. 295) B.E. 2548 (2005) on the Determination of Quality or Standards of Plastic Containers (dated 30 December 2005) was repealed.

 

The new standards, which entered into force include definitions, general safety requirements, quality standards for food packaging made from recycled plastic, as well as labelling and other requirements.

This addendum deals with:

  • Modification of final date for comments
  • Withdrawal of proposed regulation
  • Modification of content and/or scope of previously notified draft regulation
  • Change in proposed date of adoption, publication, or date of entry into force

 

In case the addendum extends the scope of the previously notified measure in terms of products and/or potentially affected members, a new deadline for receipt of comments should be provided, normally of at least 60 calendar days.

The Chilean Ministry of Health opened, on 22 August, 2022, a consultation on proposed amendments to the Chilean Food Health Code. The proposals would completely modify Title III of the Code – which regulates food additives – by eliminating 15 of its 30 articles, and replacing a further 14 articles. Only one article – on the definition of food additives – would be left untouched. 

 

In addition to the Codex Alimentarius, the new rules establish regulations in the EU (EFSA specifications) and the US (Food Chemical Codex and FDA specifications) as secondary options to assess the identity and purity of food additives.  

 

Furthermore, the Chilean authorities would establish a technical norm listing allowed food additives and their authorized uses, use conditions, and limits. The Ministry of Health has already drafted this technical list, on which comments can also be submitted during the consultation period. 

 

Finally, the rules also address the labelling obligations for food additives. 

 

The drafts are open for consultation until November 30, 2022. They can be accessed on the Ministry’s website
 

Colombia has updated its registration process and requirements for the registration of “chemical pesticides for agricultural use” (PQUA) in line with changes to Andean Community (CAN) legislation. 

 

On August 1, 2022, Resolution 1580 of 2022 of the Colombian Agricultural Institute (ICA) entered into force. The Resolution adapts the notification process to changes to recent changes to CAN law, which sets out the regulatory framework for PQUA.


PQUA were first regulated at a regional level in the Andean Community in 1998, when Decision 436 introduced common registration, control and labelling obligations for all Member States (Bolivia, Colombia, Ecuador and Peru). It was accompanied by Resolution 630 (from 2002), which established a detailed technical manual completing the framework. Under the system, both economic operators involved in the PQUA value chain and the pesticides themselves must undergo registration, with the objectives of protecting human health and the environment, promoting good agricultural practices, and ensuring the effectiveness of agricultural products. 


While the overall structure is maintained, recent updates in CAN law have brought in new versions of both the general framework (now established in CAN Decision 804, adopted in 2015) and the Technical Manual (currently Resolution 2075, established in 2019). 


The recent ICA Resolution 1580 of 2022, adopted in February, incorporated these changes to Colombian legislation and updated the registration process in the country. For operators and products registered under the former framework, it contains a three-month transitional period during which registrations can be transferred without fees. Given that the Resolution entered into force on August 1, 2022, the transitional period will last until November 1, 2022. Afterwards, any applications will be considered to be new registrations and be subject to the new framework. 

The Mexican government is currently consulting on proposed updates to its standard governing Transport Documents for dangerous goods (NOM-043-SCT/2003). The proposed new standard (NOM-043-SCT-SEMAR-ARTF-2022) would update Transport Document requirements to bring them into line with the most recent revision of the UN Model Regulations on the Transport of Dangerous Goods (Revision 2022), which was adopted in 2021. 

 

The proposed standard would be of general application, being required of shippers, carriers and recipients across all transportation methods. 

 

Comments on the draft – accessible here – can be submitted for 60 days after its publication in the Mexican Official Journal, which took place on September 7, 2022. 
 

The latest update of the Pest Control Products Bill, 2022 was published in Kenya in April 2022. It represents an urgent update to the existing Kenyan pesticide regulation.

After various analyses, it has been found that Kenya was exporting food and other kinds of products containing pesticide residues above the maximum allowable levels. The study was conducted by renowned organization Kenya Organic Agriculture Network. During their study, they found an excess level of acephate in some samples of tomatoes that were collected from Kirinyaga County. Acephate is an endocrine disruptor that possibly has some carcinogenic and neurotoxicant effects.

If the proposal is amended, Kenya will have to promote Good Agricultural Practices (GAPs), as per the Food and Agriculture Organization (FAO).  The main aim of GAPs is to improve the quality, safety, and sustainability of food and agricultural products and at the same time maintain environmental, economic, and social sustainability.

The function of the pesticidal regulation is to set a limit for the residue allowed in foods or animal feeds i.e., Maximum Residual Limit (MRL) as per international standards. The government of Kenya has put a limitation on the active ingredient only, which has heavy curtailment on other jurisdictions and halts adaptation of GAPs.

In short, the pesticide legislation in Kenya does not provide the legal basis for urgent and comprehensive action against the negative effects of these harmful chemicals’ environment. Therefore, the Kenyan authorities must fast-track the passage of the proposed Pest Control Product Bill, 2022 and implement GAP as soon as possible.

Saudi Arabia is the newest country to issue a Restriction of Hazardous Substances (RoHS) regulation, requiring relevant Saudi manufacturers and importers of electric and electronic equipment (EEEs) to comply with this law from 5 January 2022. This regulation is published by the Saudi Standards, Metrology, and Quality Organization (SASO). Various products on the market were discovered to contain dangerous substances which show a serious danger to the safety of the consumer and the environment. This implementation was set to begin on 9 July 2021 and postponed to 4 July 2022, due to industries from countries like the US and China expressing their concerns over the short timeline, which can be again extended till March 31, 2023, to affect manufacturers of different types of appliances.

RoHS stands for Restriction of Hazardous Substances. RoHS, also known as Directive 2002/95/EC, originated in the European Union and restricts the use of specific hazardous materials found in electrical and electronic products (known as EEE). All applicable products in the EU market after July 1, 2006, must pass RoHS compliance.

According to restrictions, the chemical restriction level is standardized of the following substances so, that every relevant product undergoes testing to make sure it does not go beyond chemical restriction levels.

Hazardous substances in electrical equipment and appliances

Maximum percentage of content allowed

Lead (Pb)

0.1%

Mercury (Hg)

0.1%

Hexavalent Chromium (Cr6+)

0.1%

Cadmium (Cd)

0.01%

Polybrominated Biphenyl Ethers (PBB)

0.1%

Polybrominated Biphenyls (PBDE)

0.1%

 

Large-scale industrial stationary machinery, medical devices, military equipment, large-scale fixed installations, and aerospace equipment are exceptions to this regulation. Penalties, as well as the removal of a product from the market, is the step taken whenever a manufacturer fails to abide by the regulatory compliance.

Timeline updates to Compliance-

  • Electrical household appliances:                4 July 2022
  • Large electrical household appliances:     2 October 2022
  • Telecommunication and IT equipment:   31 December 2022
  • Lighting equipment:                                     31 March 2021

Manufacturers have to stay up-to-date on amendments and integration, as more equipment and appliances will be added in the future.

On 8 August 2022, the Saudi Food and Drug Authority (SFDA) updated the permitted use of Methyl N-Methylanthranilate (MNM) in cosmetic products. In cosmetics, MNM acts as a fragrance. It is used in fine fragrances, shampoos, soaps, and many other types of cosmetics. The update will come into effect from 1 July 2023.

Iearlier in EU, the permit to use MNM in cosmetic products was updated. Under Annex III of (EC) 1223/2009 the European Commission released Regulation (EU) 2022/135, restricting the use of methyl-N-methylanthranilate in cosmetic products. The regulation was released on 31 January 2022 and has been effective since 21 February 2022. 

According to SFDA Circular 24366 and EU regulation (EU) 2022/135-

Restriction

(a) Leave-on products

(a) 0.1 %

For (a): not to be used in sunscreen products and products marketed for exposure to natural or artificial UV light

(b) Rinse-off products

(b) 0.2 %

For (a) and (b):

- Do not use with nitrosating agents

- Maximum nitrosamine content: 50 μg/kg

- Keep in nitrite-free containers

                                                                                                                                                                     

On the basis of the latest evidence and studies the new MNM restrictions are updated.

Cosmetic products must comply with the update by manufacturers, warehouse managers and importers.

 

New Zealand has in spring 2022 released the Waste Minimisation (Plastic and Related Products) Regulations 2022 that are a subject of the Waste Minimisation Act 2008.  

The regulations' purpose is to ban the manufacture and sale of certain plastic products, in particular single-use plastics. The products that fall under the manufacturing and selling ban are:  

(a) plastic drink stirrers that are single use: 

(b) plastic or synthetic cotton buds that are single-use, unless they are used, or intended for use, — 

(i) as a medical device (as defined by section 3A of the Medicines Act 1981) that is not sold by retail; or 

(ii) in a veterinary clinic for diagnosis or sampling; or 

(iii) in a commercial food laboratory for food sampling; or 

(iv) in a laboratory for scientific investigation (even if they are first used for field sampling); or 

(v) as part of any kit or other material to test for any medical or scientific matter, including infection or immunity in an individual or animal, and to produce a result without analysis at a laboratory: 

(c) any product that contains plastic with pro-degradants: 

(d) PVC food trays or containers: 

(e) specified polystyrene packaging for food or drink. 

Please note that this even applies to plastics used to package a product that already has one layer of packaging.  

The Waste Minimisation (Plastic and Related Products) Regulations 2022 will be enforced from 1st October 2022.  

 

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