GPC Newsletter Sep-2020

We are excited to share important news regarding the evolution of our company and if this change will affect any of your on-going or future activities with us.

We are delighted to announce that our Indian Legal Entity has recently changed its registered name from Nagpur Sustainability Support Services Private Limited (NSSS) to GPC Regulatory India Private Limited (GPC India) as part of the recent acquisition by the Global Regulatory Compliance Holding. The name Global Product Compliance is also an indication of our global presence for supporting your company in different countries/regions for respective chemical regulations.

The new name GPC Regulatory India Private Limited (GPC India) will be officially effective from 1st Oct 2020.

Read more  here   

The Government of the Russian Federation has identified responsible institutions for implementing the Eurasian Technical Regulation 041 (TR 041), an official decree published on 16 September 2020. The Ministry of Industry and Trade of Russia and the Agency of Wellbeing and Consumer rights are two government organizations that will be assigned for executing the TR 041.  

The Ministry of Industry and Trade of Russia (Minpromtorg) will be the main authorized federal executive body. The major tasks of Minpromtog are: the notification of New Chemical Substances (to be a part of the national inventory).  

• To perform notification of new chemical substances by entering information on new chemical substances into the national part of the inventory.  
• To perform registration (notification and permissive) of chemical substances based on the documents and information submitted by the applicant, information  by Ministry’s expert organization and the conclusion of Agency of Wellbeing and Consumer rights (hereafter referred to as Rospotrebnadzor) in case if chemical products contain new chemical substances;  
• Formation and maintenance of the national (Russian) part of the inventory of chemicals and mixtures of the Eurasian Economic Union;  
• Representation of interests of the Russian Federation in interaction with international organizations concerning the regulation of chemicals and mixtures.  

Rospotrebnadzor has been appointed as the authorized federal executive body to carry out following tasks:  

• Notification of new chemicals and providing the corresponding conclusions to the Ministry of Industry and Trade of Russia (Minpromtorg);  
• Assessment of New Chemical Substances in terms of their danger to human health and the environment and providing a corresponding conclusion to Minpromtorg.  
• To assist (within its competence) the Minpromtorg in implementation of TR 041.  

According to the decree, a number of federal executive authorities, such as the Ministry of Natural Resources of Russia, the Ministry of Economic Development of Russia, the Ministry of Agriculture of Russia, the Ministry of Energy of Russia, the Ministry of Health of Russia and Rosstandart, might be involved in the process of implementing TR 041 in the near future.  The next step of TR 041 is a ratification of the above services and a finalization of formation of a national part of the inventory in Russia by the end of 2020.

According to the latest update from the Ministry of Environment and Urbanization of Turkish Republic, pre-SIEF notification module in KKS (Chemical Registration System) will be kept active even after the pre-registration deadline, 31st December 2020. 

The reason was explained to be make it easy for registration activities to participate in SIEF (Substance Information Exchange Forum).

Although the Ministry have just made late pre-registration possible, it was also pointed out that substances that are not pre-registered by the upcoming deadline will not be allowed to placed in the Turkish market unless they complete both pre-registration and registration processes.

This can be interpreted that a longer process will be needed if the pre-registration is not complete before the deadline.

It is already known that after the deadline, substances that are pre-registered will not need to register until the end of 2023, the deadline for registration, to be placed on the Turkish market.

To protect your business interests in Turkey and be able to export your substances without much effort and expense, we can pre-register your substances as your Only Representative (OR).

You can send your substance list to us from this link and request a quote, as well as getting information if your substances need to be pre-registered or not.

The Ministry of Environment and Urbanization of the Turkish Republic has published the draft of the price list for registration fees.

It is known from the regulation from before that registration, updating registration, request on confidentiality, product & process-focused R&D notification, authorization (permit) application, and evaluation of authorization activities will be subject to official fees.

According to the published list, the minimum fee will be 50 Turkish Liras (5.5 EUR)  for joint registration up to 10 tpa by a micro-sized company and the maximum fee will be 15k Turkish Liras (1640 EUR) for self-registration more than 1000 tpa by a large-sized company.

It is also pointed out that these fees are subjected to change as the final list will be published by 2021.

Keep updated by following our newsletters and GPC Gateway for most recent information about Turkey REACH.

You can find the list with Euro equivalents here. Kindly keep in mind that prices in Euro might not represent an accurate value as the currency exchange rates differ.

India is finalizing plans to increase the number of chemicals and petrochemicals to be covered by mandatory certification. The Ministry of Chemicals and Fertilisers, the responsible authority to issue list of products on which mandatory certification is to be required, plans to make 72 chemicals and petrochemical standards mandatory. Within these standards, domestic and foreign companies will be required to obtain permits before they can import, manufacture, or use the affected substances. 

Since 2018 India has notified 29 mandatory standards covering 32 substances to WTO:

• Notification for Phthalic Anhydride, Poly Aluminium Chloride and Caustic Soda (with notification deadline for comments in Feb. 2018, June 2019 and Jan. 2020)
• 21 standards (covering 22 substances) notified to WTO (with deadline for comments of April 2020)
• 5 standards (covering 7 substances) were notified to WTO (with deadline for comments of Sep. 2020)

The purpose is to standardise the chemicals to conform with the harmonised system of coding, which is followed internationally and make it more transparent in order to reduce fake and substandard quality. The Bureau of Indian standards (BIS), the national Standards Body of India, will be responsible for the certifying and enforcing agency for these mandatory standards.

The Thailand Cosmetic Regulation or Cosmetic Act B.E. was officially finalized in the year 1992. Thailand’s Ministry of Public Health has updated its lists of prohibited and restricted substances for use in cosmetic products. 

Many of the changes bring the country into line with the Association of South-east Asian Nations (Asean) Cosmetic Directive (ACD), to which Thailand is a signatory. To change the status the act was legitimately amended in the year 2015 and was published in Royal Thai government Gazette on 8th September 2015 and came into force from 9th September 2015.

The Act was amende by the Thailand’s FDA on June 26, 2020 and was enforced on June 27, 2020, It requires information on those that contain specific thresholds, conditions of use and product types for each substance.

The substances on the list which are subject to updates are: 

• triclosan – the ministry set an allowable concentration limit of 0.3 % for 11 types of rinse-off products and 0.2% limit for mouthwash. These limits are lower than those imposed by some Asean countries;
• tagetes minuta flower extract/oil – the ministry set a maximum concentration limit of 0.01% for leave‐on products and 0.1% for rinse‐off products; and 
• tagetes patula flower extract/oil – the ministry set a maximum concentration limit of 0.01% for leave‐on products and 0.1% for rinse‐off products.

Cosmetics products must be labelled properly according to the  requirements of Thai legal labelling. It should be done within  30 days before placing it to Thailand’s market. According to the ACD, these limits will be effective from 19 December.

In Thailand the following enforcement dates apply:

• 27 June 2020 – for new products entering the market; and
• 27 June 2021 – for products already existing on the market prior to 27 June 2020.

Cosmetic products cannot exceed these concentration limits and conditions of use without prior approval from the authorities.

Prohibited chemicals

The ministry has also added seven chemicals to its list of those banned for use in cosmetic products. These include: 

• ketoconazole;
• 3- and 4-(4-hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC);
• 2,6-dihydroxy-4-methyl-benzaldehyde (atranol); and
• 3-chloro-2,6-dihydroxy-4-methyl-benzaldehyde (chloroatranol).

The following are banned from use in hair dye products in line with restrictions under the ACD:

• 2 -chloro-p-phenylenediamine (INCI) 2 -chlorobenzene -1,4 -diamine;
• 2 -chloro-p-phenylenediamine (INCI) 2 -chlorobenzene -1,4 -diamine and its sulfate; and 
• dihydrochloride salts.

Manufacturers, importers, distributors and retailers are all prohibited from using these chemicals in cosmetic products. The restrictions came into force on 27 June, 2020. 

In Australia, new scheme the Australian Industrial Chemicals Introduction Scheme (AICIS) replaced 30 year old National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1st July 2020. This new scheme regulates the introduction i.e. manufacture and import of industrial chemicals in Australia. It is advisable for companies to understand the new requirements and different categories for new introductions to comply with the new Scheme.  

The aim of new scheme is to protect the health of Australian population and environment, while also keeping industry competitive and promoting access to safer chemicals. 

Key Changes from 1st July 2020: 

• There will be 6 categories of introduction with different regulatory requirements that are proportionate to the likely level of risk 

• Lower risk chemical introductions will have streamlined introduction pathways, resulting in reduced regulatory burden for industry. 

• There will be improved protections for the public, workers, and the environment towards higher risk chemicals. 

• Improved approaches to reviewing chemicals on the market. 

• There will be increased focus on pre and post-introduction evaluation and monitoring of chemicals.  

• Restriction on the use of animal test data for supporting the introduction of ingredients used in cosmetics. 

The final draft of the Indian Chemicals Management and Safety Rules (CMSR – India REACH) is out now!

Next Step: After final optimization, Indian CMSR will go for the World Trade Organization (WTO) Notification (60 Days)

The Indian CMSR would likely come into force from the first quarter of 2021.

Updates from the previous (4th Draft) version includes:

• National Chemical Authority to be Established
• All substances to be Notified
• 1st List - 750 Priority substances to be Registered
• Foreign Companies to Appoint Authorized Representative
• Pre-Import Notification required for substances designated as Hazardous

You can download the Final Draft of the Indian CMSR here

GPC India is fully equipped to provide an end to end regulatory compliance solution to companies in and outside India.

For further details on Indian CMSR please contact us at compliance@in.gpcregulatory.com