GPC Newsletter Dec-2021

GPC prepares a series of webinars in January 2022, register to reserve your spot! 

What you need to know about Agrochemical Regulations in EU and UK

Date: January 13

Time: 10:30 CET, 15:00 IST

Event Description: As one of the developed economies, the EU has a highly regulated system to manage the placing of Plant Protection Products (PPP) in its market. Following the end of the Brexit transitional period, an independent pesticide regulatory regime came into operation in the UK (Great Britain) from 1st January 2021. Our webinar will provide a summary of EU and UK requirements for PPP and explain the compliance requirements and benefits.

Register here. 

SCIP Database: Are you affected and how to comply?

Date: January 19

Time: 10:30 CET, 15:00 IST

Event Description: Are you a manufacturer who supplies goods in the EU? If so, you can find the following webinar useful and informative to understand your obligation for reporting to SCIP database.

On 5 January 2021, a new regulation came into force regulating the obligation to report to the SCIP database. Companies exporting an article in the European market have to report whether the articles contain any of the SVHCs on the REACH Candidate list if the substance comprises more than 0.1 % of the article by weight. The purpose of SCIP database is to ensure information about SVHCs is available throughout the whole life cycle of products and materials, including at the waste disposal stage.

This webinar will take you through the SCIP notification process as well as share all important information.

Register here 

Agrochemical Compliance in South America: Brazil, Argentina, Columbia, and Paraguay

Date: January 20

Time: 10:30 CET, 15:00 IST

Event Description: In each city, there are agencies responsible for regulating the research, labelling, packaging, storage, etc of pesticides and related components. This webinar will mainly provide an overview of agrochemical regulations in South America and the compliance requirements for agrochemicals.

Register here 

EPA pesticide registration and data compensation in USA. A case study of Prothioconazole

Date: January 27

Time: 10:00 CET, 14:30 IST

Event Description: As the Environmental Protection Agency (EPA) in the USA, the agency’s main responsibility is to register and supervise the use of pesticides within the country. To produce, import, and use pesticides in the USA, we have organized this webinar to help you know and understand the compliance requirements that has been set by the EPA.

Register here 

Regulatory Frameworks for Food Contact Materials (FCMs) in India

Date: January 28

Time: 10:30 CET; 15:00 IST 

Event Description: Chemicals used in food packaging and food contact materials (FCMs) have become an increasing source of concern in recent years. This webinar is prepared for you to understand the regulatory obligations in FCMs and the legal framework regulating FCMs.

Register here 

Comply with UK-REACH: How can companies prepare?

Date: January 31

Time: 10:30 CET; 15:00 IST 

Event Description: The EU REACH Regulation was brought into the UK law on 1 January 2021, and this is known as UK REACH. UK REACH requires UK manufacturers/importers to register their chemical substances to the Health and Safety Executive (HSE) by the designated registration deadlines if the tonnage exceeds 1 TPA. This webinar will help you know more about your obligation under UK REACH.

Register here 

The European Commission published a Regulation amending several annexes of the cosmetics regulation, prohibiting certain substances from use in cosmetics. This regulation was published on the 3rd of November and came into effect on November 23, 20 days after its publication.

According to the new regulation, 23 Carcinogenic, Mutagenic or Reprotoxic (CMR) substances are banned from use in cosmetics production, effective from March 1st, 2022. The amended annexes are Annexes II, III, and V and some of the substances subjected to the ban include the following:

• Zinc pyrithione
• dioctyltin dilaurate, stannane, dioctyl-,bis(coco acyloxy) derivatives;
• 2-methoxyethyl acrylate;
• diisooctyl phthalate;
• bis(α,α-dimethylbenzyl) peroxide; and
• dichlorodioctylstannane. 

More detailed information about the list of substances can be accessed here.

Last update: 2021-12-17

In a letter of 9 February 2021, Steve Elliott, Chief Executive of the UK’s Chemical Industries Association called upon the UK government to repeal the UK REACH requirement for duplicate registration datasets. Under the current situation, companies seeking to register substances under UK REACH must replicate the data used to register under EU REACH or purchase it again. This, according to the industry representatives, may result in a 1 billion pounds extra cost for chemical manufacturers and importers.

To mitigate such extra costs in response to the industry’s concerns, George Eustice, the UK’s Secretary of State for Environment, Food and Rural Affairs, announced on December 6th that the government is considering an amendment of UK REACH. The solutions under consideration mostly coincide with those put forward by industry representatives: which only requires registrants to submit already publicly available data for most substances, and full datasets for the most hazardous ones.

To secure additional time for the industry while exploring the feasibility of this new model, the UK government announced that it will hold a consultation on whether to extend the deadlines for providing full registration data on substances that have been notified via the Downstream User Import Notification (DUIN).  

Under the current regulatory framework, substances that have been DUIN-notified need to be fully registered by 27 October 2023, 2025, or 2027 depending on their tonnage band and risk profile (see table below).

However, subject to the outcome of the consultation, the government might extend the 27 October 2023 deadline to 27 October 2025. Similar plans are also being considered for the 2025 and 2027 deadline.

Last update: 2021-12-15

According to the Indian researchers who compiled the chemicals’ database, there is a need for better risk assessment and regulation of fragrance substances in children's products. 

Due to the collaboration between two Research Institutes: the Institute of Mathematical Sciences in Chennai, India and the Max Planck Institute for Mathematics in the Sciences in Leipzig, Germany; a Fragrance Chemicals in Children's Products (FCCP) database of 153 fragrance substances has been created using published literature. 

The team, led by Areejit Samal, classified the substances based on their structure. Several of the fragrance chemicals were discovered to be potential carcinogens, endocrine disruptors, neurotoxicants, and skin sensitizers. In vitro data from the US Environmental Protection Agency's ToxCast programme helped in identifying seven skin sensitising chemicals in the FCCP database. 

It is pointed out that children can be exposed to fragrance chemicals through their skin, inhalation, or ingestion. However, the fragrance industry's safety testing has primarily focused on dermal exposure, therefore, more research is needed on toxicological or disease pathways associated with other routes of fragrance chemical exposure in children. 

The researchers believe their database will be useful to regulatory agencies as it will enable future toxicological and exposome research and facilitate risk assessment of fragrance chemicals. 

Last update: 2021-12-17

On the 1st of December 2021, China’sNational Medical Products Administration  (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old.

From 1 May 2022, newly registered children’s cosmetics must attach the logo. If the cosmetic is already registered or filed when the notification is published, companies must update their labels before 1 May 2023.  

According to the requirements, the label must be at least 1cm wide if the outer surface area of a product is smaller than 100cm2, while if it is larger, then the label must be at least 2cm wide.

Children’s cosmetics are defined as cosmetics made for children under 12 years old. NMPA defines children’s cosmetics as those products that have functions such as cleansing, moisturizing, and sun protection. China’s NMPA announced children's cosmetic working plan in October which is planned to come into force on January 1, 2022. 

For more inquires relating to China REACH and cosmetic regulation, please contact compliance@gpcregulatory.com  

Last update: 2021-12-15

On November 23rd, 2021, Taiwan’s Environmental Protection Agency amended the Regulations of New and Existing Chemical Substances Registration and extended the submission of 106 PECs to 5 years. Considering the impacts of COVID on the industry, companies will need extra effort and time for supply chain communication. Taiwan’s EPA then decided to extend the submission deadline for Standard Registration of all tonnages to 5 years. Standard Registration is applicable to 106 Priority Existing Chemicals (PECs) and the list remains the same.

In the draft amendment published on May 27th, EPA mentioned that registrants are encouraged to use non-animal testing alternatives with reduced fee incentives. This suggestion was postponed in the latest amendment by EPA due to the extra resource that will be needed for data review and supply chain communication.  

For the substances that initially had submission deadline within 3 years, the updated deadline would now be 2024.

Last update: 2021-12-21 

After four years of drafting the framework, Colombia finally promulgated a robust chemical management regulation. Decree 1630, published on November 30, 2021, sets the ground for implementing a national chemical inventory. 

Decree 1630/2021 targets hazardous substances for industrial use identified by the Globally Harmonized System (GHS) of classification and labelling. The production, import, use, marketing, distribution, and transportation activities are requested to comply with the provisions.  However, substances already addressed by existing regulations, unknown/variable composition, complex reaction products/of biological materials (UVCB), impurities, articles, polymers and monomers, intermediaries, and in customs transit are exempted. 

Consequently, manufacturers or importers of chemical substances over 100 kg per annum are required to submit information to the authorities. This information include: 

• Manufacturer or importer information 

• Substance amounts manufactured or imported 
• Substance identification, including CAS number 
• Substance hazard classification in accordance with the GHS 
• Identified substance uses 

The aforementioned information will be consolidated into the national inventory of chemical substances present in Colombia. This database will be used, among other things, to identify priority substances and chemicals requiring a risk assessment.   

Overall, the new framework for industrial chemical substances is a cooperation between the Ministries of Environment, Health, Labor, and Commerce. These Ministries will work together to implement and make the national inventory operational with a 6-month deadline, additionally providing further instructions on data submission. The submission of information to the national inventory becomes mandatory within three years from the publication of such guidelines. 

See Decree 1630 (in Spanish) 

Last update: 2021-12-17

On November 15 and 16, 2021, the Committee on Technical Barriers to Trade, India published and submitted eight chemicals’ notifications to the World Trade Organization (WTO).

BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification. Product certification includes two schemes, that is, Product Certification Schemes: Scheme 1 - Indian Standards Institution (ISI) and Scheme 2 - Compulsory registration scheme (CRS). According to the BIS official website, there are 27 chemicals (Scheme I and II) that requires BIS mandatory certification. For the newly notified eight chemicals, all the notifications do not have a proposed date of adoption yet. However, the proposed date of entry into force is in 6 months from adoption. The final date for comment is 60 days from the notification, which is on January 15.

The notified substances are as follows:

1. Coconut Fatty Acids (IS 12069:1987) are produced by the hydrolysis of Coconut Oil. Coconut Fatty Acids consist of about 90% saturated fatty acids. The main fatty acids are Lauric Acid, which constitutes about 50% of total fatty acids obtained from coconut oil. Coconut Fatty Acids are used in the manufacture of Soaps and their derivatives like coco diethanol amide and coco mono ethanolamide.

2. Hydrogenated Rice Bran Fatty Acids (IS 12361:1988) is obtained by splitting, distillation, and hydrogenation of rice bran oil or by hydrogenation of distilled fatty acids obtained by splitting of rice bran oil. Rice Bran Fatty acids are used in the manufacture of soaps.

3. Lauric Acid (IS 10931:1984) is a saturated fatty acid having 12 carbon atoms. It is a raw material for making Lauryl Alcohol, which is used in the detergent industry. It is also used in Alkyd resins, Lauryl peroxides, ethanol amides etc. It is obtained by splitting coconut oils, Palm Kernel Oil etc. 

4. Palm Fatty Acids (IS 12067:1987) are obtained by hydrolysis of Palm Oils. Palm Oils are obtained from the fleshy part of Palm Fruits. Palm Fatty Acids consist of saturated and unsaturated fatty acids in equal amounts, Palmitic Acid and Oleic Acids are being the main fatty acids. Palm Fatty Acids are used in the soap industry.

5. Rice Bran Fatty Acids (IS 12068:1987) are produced by the hydrolysis of Rice Bran Oil. Rice Bran Oil is produced by solvent extraction of the layer around the endosperm of rice, known as Rice Bran. It contains 20-25% of saturated and 75-80% of unsaturated fatty acids. The main unsaturated fatty acids are Oleic Acids (40-50%) and Linolenic Acids (28-42%). These fatty acids are used in the manufacture of soaps.

6. Rubberseed Fatty Acids (IS 12124:1987) are produced by hydrolysis of Rubber seed Oil. Rubber seed oil is obtained from seed kernels of Rubber trees. Rubber Seed Fatty Acids contain Linolenic Acis (30-40%), Oleic Acid (17-30%) and Linoleic Acid (22- 24%) and other saturated fatty Acids like Palmitic acid and Stearic Acids.

7. 1,3 Phenylenediamine (IS 17450:2020) is an important dye-intermediate, polymer additive, fibre intermediate and used in photography. Since it is used in dyestuffs required for dyeing of textiles, it is very important to adhere to purity levels indicated in the standard. The excess impurities in the dyes may enter the human chain through textiles, impacting the health. If the technical parameters indicated in the standard are not observed, it shall be detrimental to plant life and environment.

8. Acid Oil (IS 12029:1986) is produced by acidification of soap stock obtained during refining of oils. It is used for producing low grade soaps. The large quantity usage and imports of Fatty acids and possible health impact of low purity.

For non-Indian manufacturers to comply with BIS certification, companies can appoint Authorized Indian Representative (AIR) to fulfil their obligations. For chemical compliance under BIS, companies should also conform to the individual Indian standards. Manufacturers of the products listed on Scheme 2 should apply for registration from Bureau of Indian Standards (BIS) after getting their product tested from BIS recognized labs. After registration, manufacturers are then allowed to put the Standard Mark on their products.

Contact GPC for BIS related compliance advice, compliance@gpcregulatory.com

Last Update: 2021-12-21

On November 18, 2021, the Ministry of Environment approved complementary provisions to Decree 9/2019, which is the current legislative instrument for the management and handling of Waste from Electrical and Electronic Equipment (WEEE). Decree 35/2021 brings obligations for lighting appliances and medical/laboratory equipment to an Extended Producer Responsibility (EPR) perspective. 

Altogether, WEEE is divided into 11 categories. Each Electrical and Electronic Equipment (EEE) category is exemplified below: 

The Ministry of Environment (MINAM) established an annual progressive collection goal per year for 2020-2024 according to WEEE categories calculated as an annual manufacturing/import average, considering the last 3 years as a baseline: 

Besides the recollection goals, the regulations also impose obligations to producers, distributors, marketers, and operators. It is relevant to note that: 

• Producers (whether manufacturer, assembler, or importer) are requested to submit a Waste Management Plan for Electrical and Electronic Equipment to MINAM. Additionally, producers must prepare an annual declaration, which must be submitted through the Information System for the Management of Solid Waste (SIGERSOL). It is also expected from the producer to take, free of charge, WEEE back from end-users, regardless of whether it is from a third-party generation.  
• Distributors and marketers are required to implement collection points for take-back articles, redirect collected WEEE to waste management schemes, and educate customers about the proper handling, segregation, and delivery on collection points.  
• Operators responsible for WEEE recovery plants are in charge of collecting, transporting, and recovering (dismantling/disassembling) WEEE. The operator's annual declaration is similar to the producer's declaration, yet, more detailed in terms of treated WEEE amounts, origin and categories. 

It is recommended for target groups under imposed responsibilities to align with the aforementioned obligations, consult integrally the legislations, and if necessary, request support from an advisory team. Finally, consumers also have the duty to cooperate. They can collaborate simply by retuning WEEE to a registered collection point among the various available in Peru.  

Last Update: 2021-12-20

The Brazilian Deputies’ Chamber approved Law Bill 6.120/2019, which proposes the creation of a national chemical inventory aimed at consolidating information of chemicals imported into the national market. 

The Law Bill, having been in the possession of the Deputies’ Chamber Environment and Sustainable Development Commission (CMADS) since early 2019, now seek approval from the other three commissions. In unanimous consent, the legislation is immediately forwarded for official publication. 

The regulation had one amendment supported by deputy Rodrigo Agostinho. The modification brought back essential aspects from the National Committee on Chemical Safety’s proposal presented to the Congress in 2018 which was shelved immediately Bolsonaro’s government took place.  The National Chemical Safety Committee's proposal is still known for its technical criteria and capacity to mediate representatives from the chemical sector, civil society, academia, and NGOs until today.

The modification highlights are related to the reestablishment of the Technical Committee for the Evaluation of Chemical Substances and the Deliberative Committee for Chemical Substances and the reworking of the risk management, inspection, infractions, and sanctions activities.  

The proposal is part of the country’s ambition to develop an efficient management of chemicals, given the international trend. However, despite the gradual advancements, it is still uncertain when the proposal would be officially adopted. 

On a regional context, Latin America is fast developing an integrated chemical policy. The most recent cases are Chile and Colombia, which have already enacted the law on comprehensive management of chemical substances in 2021. 

Last Update: 2021-12-20

On the 25th of November 2021, the Brazilian National Congress sanctioned a legislation concerning the mandatory controlled disposal of polychlorinated biphenyls (PCBs). Law 14250/2021 complements Decree 5472/2005, which is responsible for promulgating the Stockholm Convention on Persistent Organic Pollutants (POPs) in the country. 

Besides the phasing-out of PCBs, equipment and waste containing PCBs are subject to the decontamination process before being discarded. This includes, for example, materials, oils, fluids, and other operational substances.   

 In addition, businesses handling equipment or residues contaminated with PCBs are required to prepare and submit to the environmental authority an inventory with a list of supplies in stock, operational and stored equipment, and contaminated waste owned. The environmental authority will issue a manual within 180 days for this purpose.  

Law 14250/2021 imposes provisions to all holders of PCBs or contaminated equipment/substance, including the appropriate final destination of its residue/waste. The PCB inventory will have up to 3 years after the date of the law’s publication to be prepared, available and sent to the competent environmental agency

Last Update: 2021-12-20