GPC Newsletter Sep-2020


Announcement

We are delighted to announce that Global Product Compliance (GPC) has joined hands with Auxilife Scientific Services Pvt. Ltd. as a part of the recent acquisition by GPC on the 1st of July 2020.

This alliance will strengthen our existing resources and expand our global presence in the agrochemical sector. We will now be able to comprehensively support your aspiration in different countries/regions for agrochemical regulatory compliance.

This teaming up strengthens GPC and Auxilife’s expertise, skills, and global reach across sectors:

  • Complete regulatory compliance for plant protection products, biocides, drugs, cosmetics, medical devices, food, and feed additives.
  • Team of experts positioned in India and Germany.
  • Global agrochemical regulatory compliance support.

Read more here  

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   


Regulatory News

With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition period market access would continue the same terms as before. During this transition period, the UK will continue to remain strongly committed to the effective and safe management of chemicals. The UK will exit the transition period on the already set date- 31st December 2020. 

The EU and the UK have formally begun the ninth and final round of talks on a post-Brexit free trade treaty on September 29 which are currently ongoing, and the outcomde of negotiations is still awaited. 

During the transition period: 

  • EU REACH will continue to apply in the UK and businesses do not need to take any action to comply with UK REACH 

  • There is no requirement to transfer UK held registrations to an EU 27 legal entity in order to retain EU market access 

  • Registrations, authorisations and restrictions in place before the UK left the EU continue to be valid 

  • The process for registering new chemicals under REACH remain unchanged, UK companies are still required to register with the European Chemicals Agency (ECHA) 

  • The UK will recognise all new decisions relating to REACH made by the EU 

Post transition period: 

The Health and Safety Executive (HSE) will play a key role in the UK's chemicals regulatory process together with the Department for Environment, Food and Rural Affairs (Defra) and the Environment Agency (EA) to ensure the effective and safe management of chemicals to safeguard human health and the environment. 

The Department for Environment, Food and Rural Affairs (Defra), early in September 2020, has announced tonnage band specific, staggered submission deadlines that will apply for the full submission of data. The full registration dossiers would hence need to be submitted within 2, 4 or 6 years, starting from October 28, 2021.  

In a private and very recent (September 2020) communication of Global Product Compliance (Europe) AB with the Health and Safety Executive (HSE), they have indicated that during this transition period, the UK businesses need to continue to comply with EU REACH in their current roles and in their supply chains. The UK authorities have indicated that, the extent to which the provisions in UK REACH will come into effect at the end of the transition period will largely depend on the outcome of the UK-EU trade deal negotiations. Based on the outcome of negotiations, the authorities might need to change some or all the provisions and any transitional provisions will give sufficient time span for the companies to comply. The HSE authorities have indicated that the future legislation is likely to be similar to that which was drawn up for a “no deal” scenario (UK REACH).   

Global Product Compliance (Europe) AB has already set up a UK based OR entity ‘GPC UK’, to support its existing and new potential clients, to be able to comply with the challenges posed because of Brexit on substance exports to the UK.  

For more information or queries, please write to us at compliance@uk.gpcregulatory.com  

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.  

Rospotrebnadzorhas 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. 

New chemical regulation Australian Industrial Chemicals Introduction Scheme (AICIS) came in force in Australia from 1st July 2020 and to enable the compliance with the new requirement of AICIS, Australian Department of Health (DOH) has published a guidance for importers and manufacturers specifically for those chemicals which are used in food-contact articles.  

Food contact materials like food wrapping, food containers, coatings on the inside of food cans, and coatings on the inside of water storage tanks are covered in this guidance document however chemicals that are used in non-food contact materials like side of glass or metal articles, or ones used in cardboard that does not directly contact food are considered exempted from the AICIS requirement. 

As per this guidance document food contact material can be categorised as “exempted,” “reported,” or “assessed”. Record keeping requirements for exempted and reported chemicals those are used in food contact materials are also clearly mentioned in the guidance. 

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

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