GPC Newsletter Nov-2021


Announcement

Agrochemical Webinar Series 2021 Dec. - 2022 March 

Indian Chemical and Petrochemical Conference (ICPC) 2021 - Dec. 16-17th

 

China Pesticide Registration Updates

Date: December 9, 2021

Time: 10:00 CET/17:00 CST/14:30 IST

Event Description: To assist foreign pesticide producers to meet the Chinese pesticide registration requirement, this webinar will present an overview of the latest pesticide registration policies and data requirements for successful registration. This webinar will cover both Mainland and HK China. Register 

Agrochemical Compliance in South East Asia countries

Date: December 16, 2021

Time: 10:30 CET/15:00 IST

Event Description: Each country requires local citizens or organizations to register the agrochemicals. Provision of data on the chemistry, toxicity, assessment tests, and environmental effects is one of the requirements every registrant must fulfill. This webinar will further address the registration requirements and procedures for agrochemicals in Cambodia, Indonesia, Philippines, and Vietnam. Register 

Indian Chemical and Petrochemical Conference (ICPC) 2021

Date: December 17th, 15:30 - 17:00 IST 

Global Product Compliance (GPC) Group is honored to be invited to the ICPC 2021. In this event, GPC will present a Masterclass focusing on chemical compliance in India and UK. 

(1) India’s Draft Chemical (Management and Safety) Rules: Know your obligations and start preparing by GPC's Executive Direct Mr. Shisher Kumra 
(2) Status of Product Certification and Regulatory Demands in India: BIS as an example by Mr. Reynold D’Souza
(3) Comply with UK-REACH: How can companies prepare? by Regulatory Advisor Mr. Guillaume Ehrhard

Register 


Regulatory News

The Health and Environment Ministry of Canada has proposed a recommendation to add organic substance used in paints and six flame retardants to the country's toxic substances’ list. The six flame retardants are part of a group of ten substances that the government assessed to determine whether they have any health or environmental risks. 

These substances are to be added to Schedule 1 of the Act. The ministers also released a risk management scope document for these substances in initiating discussions with stakeholders on the development of risk management actions. Furthermore, this will allow the government to put restriction on the exposure of these chemicals.  

Out of these ten, some of the six chemicals poses risk to the environment, while others enter the environment in a quantity or concentration that may cause danger to human health. These six chemicals are:  

  • triphenyl phosphate (TPHP); 
  • tert-butylphenyl diphenyl phosphate (BPDP); 
  • bis(tert-butylphenyl) phenyl phosphate (BDMEPPP); 
  • isodecyl diphenyl phosphate (IDDP); 
  • isopropylated triphenyl phosphate (IPPP); and  
  • triethylphosphate (TEP). 

The ministries said they are planning regulatory action to minimise wastewater releases of TPHP, BPDP, BDMEPPP, IDDP and IPPP.  Also, the government will consider regulatory and non-regulatory measures to reduce dermal exposures of children to IPPP and TEP, which can be used in mattress covers and child seats. However, there is no additional action on the other four flame retardants that were evaluated in the assessment.

Companies submitted their comments on the draft screening assessment of the flame retardant group within 60 days from 6th November 2021. The final screening assessment and the proposed risk management approach is expected to come into force in November 2022.  

 

Last Update: 2021-11-30

The deadline to submit a Downstream User Import Notification (DUIN) officially expired on October 27, 2021. However, HSE recently updated its online guidance on UK REACH and announced that DUINs can still be notified, although a clear timeframe was not provided for late notifications.

Consequently, eligible GB-based importers and non-GB-based exporters should take appropriate measures to submit their DUIN as soon as possible.

DUIN is a transitional arrangement set out under UK REACH. It allows GB-based importers and non-GB-based exporters to maintain access to the GB-market for their substance provided that:

  1. Their substances are registered within EU REACH
  2. They have placed their substances into the GB market between January 1, 2019 and December 31, 2020.

After submitting a DUIN, notifiers have 2, 4, or 6 years to comply with the requirement to register their substances (depending on the risk profile and the tonnage band).

Lastly, manufacturers and importers placing substances into the GB market should keep in mind that Safety Data Sheets (SDS) must now be prepared in accordance with UK REACH. SDS needs to be provided for hazardous chemicals being supplied for use at work, whether packaged or not. SDS also needs to be provided for chemicals that are not classified as hazardous but contain hazardous substances.

 

Last Update: 2021-11-12

The Indian Department for Promotion of Industry and Internal Trade (DPIIT) amendment of the storage, handling, and packaging rules and stock reporting system for ammonium nitrate and calcium carbide came into effect on the 2nd of September, 2021.

Ammonium nitrate is a substance widely used as a fertiliser, however, it is also a major component for explosives and nitrous oxide, popularly known as laughing gas. Calcium carbide is used in manufacturing acetylene gas and generating acetylene in carbide lamps. It is also used for manufacturing chemicals used in steelmaking and as fertlisers.

The ministry sets a new safety framework to ensure that these substances are well reviewed when handling, storing, or reporting them. Considering the huge importation of ammonium nitrate in India, the new rule covers all possible risks from the point where the substance lands to its last consumption point. The new ammonium nitrate rules stipulate that:

  • A single package’s weight limit is 500 tonnes and packages must be stored two metres apart at the very least.
  • Only captive consumption are permitted for importation and storage is at least 500 metres from the port’s vicinity.
  • Importers must be licensed by the relevant authorities. Compusorily, they must file returns on consumption, stocks, identification of consignments and traceability at every point of transportation.
  • A verification of transporters and handlers must be done by the police. Each substance consignment must have at least one security guard go with it.
  • A licence issued by the Directorate General of Mines Safety must be provided for transporting ammonium nitrate from one premises to another.
  • An on-site fire fighting personnel and equipment must be available.

So also, the new calcium carbide rules require importers to:

  • Provide location-based data where the calcium carbide is stored and used;
  • Daily file accounts of receipt and sale of the substance with the relevant district authorities and the Directorate General of Mines Safety.
  • Provide the coordinates of the premises to facilitate geo-mapping.

 

Last Update: 2021-11-30

On 27th October, the National Centre for Food Safety Risk Assessment (CFSA) of China published a consultation on the approval of food additives and resins and the expanded use of FCM additives.  

There are three food additives being considered for use in FCMs. They are:  

  • acids, aliphatic, monocarboxylic (C10-C22), esters with polyglycerol – for use in plastic at a maximum use level of 0.35%; 
  • 2-propenoic acid, 2-methyl-, 1,2-ethanediyl ester, polymer with methyl 2-methyl-2-propenoate – for use in polyethylene (PE) and polypropylene (PP) plastics up to 1%;  
  • hexanedioic acid, polymer with N-(2-aminoethyl)-1,3-propanediamine, aziridine, (chloromethyl)oxirane, 1,2-ethanediamine, N,N''-1,2-ethanediylbis[1,3-propanediamine], formic acid and α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) – for use in paper and paperboard up to 0.12% (counts as the dry weight*). 

And the food contact resins that are also being considered are: 

  • polymer of ethyl acrylate, acrylic acid and styrene – for use in coating and coating film at a maximum use level of 2%; 
  • 1,3-benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and hexanedioic acid – for use in coating and coating film up to 10%; 
  • 1-isocyanato-3-isocyanatomethyl- 3,5,5,-trimethylcyclohexane homopolymer, methyl ethyl ketone oxime-blocked – for use in coating and coating film up to 15%; 
  • 1,3-benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid, dodecanedioic acid and 4,4'-methylenebis [2-methylcyclohexanamine] – for use in plastic; and 
  • propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,3-diisocyanatomethylbenzene and α-hydro-ω-hydroxypoly [oxy(methyl-1,2-ethanediyl)] – for use in adhesives with indirect contact with food. 

In addition to the addictives and resins, CFSR is considering the additional uses of the following FCM addictives:  

  • C.I. solvent red 52 – for use in in plastic polycyclohexylenedimethylene terephthalate (PCT) at a maximum use level of 0.03%; and 
  • C.I. pigment yellow 180 – for use in PCT up to 0.3%.

After the consultation period which ended on November 18, if the substance gets approved, it will be put in the positive list of GB 9685-2016 and must adhere to GB 4806.1 requirements before they can be used in FCMs.  

 

Last Update: 2021-11-30

The Swedish Chemicals Agency grants an exemption for a large amount of methylene chloride, which was banned in Sweden before now. This substance is used in manufacturing a component for lithium batteries in Eskilstuna.  

Methylene chloride is a necessary substance in producing the desired properties of the separator materials used in making batteries for electric cars. This substance is very important because there is currently no other process technology that can be used to produce separator materials and provide same properties.

This exemption is granted, according to the agency’s ability to do so for special reasons, which applies in this case. One of such special reason is that there is no alternative to the substance and while research is ongoing for getting alternatives, the company must minimize the risk of workers’ exposure to methylene chloride.

The exemption of this substance applies from the 1st of June 2023 and for two years, to a total of 2,770 tonnes of methylene chloride. Measures have been put in place by the company and accepted by the agency, to ensure that workers are not exposed to unallowable risks.

Summarily, manufacturers in Eskilstuna are allowed to use Methylene Chloride in producing separator materials from June 1, 2023, to 2025.  

 

Last Update: 2021-11-30

According to the Danish Environmental Protection Agency and Danish Consumer Council THINK Chemicals, specific children’s toys have been discovered to contain some chemicals that are problematic.

The Danish Consumer Council THINK Chemicals discovered that fidget toys, also known as pop-it or anti-stress toys have various chemicals that are harmful. Therefore, advises parents to keep such toys away from their kids. The Danish EPA also warns against the use of pea-pods bought from Wish.

Fidget toys refer to the toys that can be squeezed, pressed, pulled, or moved to keep a child’s hands active.

After testing 21 different types of fidget toys, the following were discovered:

  • Pea pod keychains from wish.com contain phthalate DIBP in high values, above the legal limit. Additionally, DIBP was banned in EU from usage in toys and other products due to its endocrine disrupting nature. The Danish EPA recommends that every pop-it pea pod be disposed as the Swedish Chemicals Agency sends a request to wish.com for a marketing halt of these products. This request was made in accordance with the agreement between several e-commerce platforms and the EU Commission (Product Safety Pledge) to be able to stop marketing products that are not documented in accordance with EU legislation.
  • Four fidgets contain PAH naphthalene, which is possibly carcinogenic. The substance’s amount is also above the German recommendation for toys that encounter children’s skin in all the four toys. The only carcinogenic PAH not prohibited in toys is naphthalene. These four fidgets are: Edamame keychain from Lightinthebox, Orange chicken from Chao Chao, Cute peanut-shaped popper from Bent, and Bendable smiley man from ABC-leg.
  • Pop-it toys contain problematic siloxanes; these are toys children play with by pushing small bubbles up and down on a silicon plate. The three pop-it toys that were tested all contain siloxanes D4, D5, and D6. These siloxanes are listed on the EU’s official list of substances of very high concern (SVHC) for dangerous to the environment and health. However, the existence of siloxanes in pop-it toys are legal and the agency is uncertain about the migration of these chemicals from the silicone to the children when they play with them.

Considering the dangers these toys are likely to pose to children, it is highly important that agencies and chemical regulation governing bodies appropriately and adequately research and regulate the chemical substances used in making toys.

 

Last Update: 2021-11-30

Circular Economy has been on the rise, and debates about its adoption, key elements, benchmarks, and range of application are prevailing than ever before. In November 2021, the Organisation for Economic Co-operation and Development (OECD) published a paper focusing on Circular Economy Labels and Information Schemes (CELIS). 

The document provides an overview of labels, certifications, and standards that address circular economy aspects, assesses the drivers and barriers preventing the leverage of such communication elements, and identifies circular economy components that can be best applied to the disclosure landscape. 

In respect to these objectives, the paper points that: 

  • Information asymmetry or scarcity negatively impact resource efficiency and circularity, leading to inefficient decision-making along the supply and value chains; 
  • Although there was an increase in environmental labeling and information schemes, studies have prioritized consumer-oriented labels while setting information disclosure business-to-business aside. Confidential business information and intellectual property rights are pointed as barriers for the information system uptake; 
  • Governments are key to enhancing and improving circular economy communication elements, for example, facilitating methodological advancements to support criteria integration (product lifespan, durability, reparability, etc.), developing an information system through regulatory information disclosure requirements, and supporting the harmonization of information systems and metrics; 

Ultimately, CELIS can play an important role in enhancing and improving circular economy activities. The paper is available in the OECD library.  

 

Last Update: 2021-11-30

In September, Chile reaffirmed commitments with the Latin American Regulatory Cooperation Forum (LARCF), an association promoting dialogue and information exchange, training initiatives, and regulatory cooperation through national chemical associations. At a recent meeting, the Chilean authorities demonstrated how the forthcoming notification platform would perform.  

Authorities intend to gradually submit the system to new usability tests; therefore, other testing and showcase sessions will take place until December 2022. Currently, the system can record new substance notifications, including:  

  • If the substance is produced or imported  
  • Substance information (official and common names, CAS number)  
  • Substance hazard class and hazard category  
  • Type of use, sector, and product category  
  • Imported/manufactured quantity  
  • Substance SDS uploads  

The substance notification was created under the new chemical management regulation (Decree 57), published in February 2021. The first notification window is scheduled between February 2024 and August 30, 2024, indicating that non-industrial substances notified after the initial notification period will be handled as “new substances”. Accordingly, an official national chemical inventory will be published by December 31, 2024.  

In Chile, manufacturers and importers shall submit updated information (e.g., tonnage bands) every two years through the notification portal as part of the notification system. In addition, certain substances are required to undergo risk assessment, although the substance list and assessment criteria have until June 30, 2022, to be published. 

 On August 23, 2021, Chile published the official list for the classification of chemical substances through Resolution 777. The list, commonly referred to as “Official List of Substances Classification”, is based on the GHS 7th version.  

Manufacturers exporting chemicals to Chile are recommended to follow up the latest regulatory obligations and start preparing. 

 

Last update: 2021-11-05

 

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