Expected to be rolled out in 2022, the landmark Chemicals (Management and Safety) Rules, commonly referred to as “India REACH” is currently under discussion in its 6th draft form. The regulation will have to be compiled by the Indian manufacturers, importers and authorized representatives appointed by foreign manufacturers once it enters into force. Under India REACH, companies must notify substances manufactured or imported ≥1 tonne/year unless exemptions apply. Once the notification period starts one year after India REACH is published, the window will last for 6 months. Data requirements include spectral data, hazard classification, uses, info on downstream users, actual quantities per year, and SDS.

 In this context, recently the leading experts shared fresh insights on the comparative chemical regulatory systems at the ‘NextGen Chemicals & Petrochemicals Summit 2022’ organized by Indian Chemical News on July 21, 2022. The panel discussion themed, ‘Updates on key chemical regulations: India (CMSR), Turkey (KKDIK) and the UK (REACH)’ was moderated by Dr Vaibhav Diwan, Global Business Development Manager, GPC Group.  

“In 2010, we proposed a roadmap for the chemical regulations which was prepared along with Chemexil and submitted to the ministry of commerce. From the year 2011 to 2018, we were actively involved in preparing the draft for national chemical policy of India. Since 2018, we have been engaged in drafting the chemical rules which were submitted to the government and became the foundation for the chemicals management and safety rules. From 2018 to 2019, the regulation underwent different drafts, around five in total. The current one is the 6th draft and it didn’t progress much due to Covid pandemic. The draft is now under legal vetting and industry feedback. We are expecting its submission to the WTO later this year or early 2023. We understand the chemical regulations in the draft stage and based on experiences from UK REACH.  There are many good points in the draft that will help the industry. Good part is also that there are more data requirements from the industry. But when it comes to timelines, these are still restrictive as only 750 chemicals have been registered,” added Dr Diwan.

 “From the petrochemical industry perspective, the timeline were short. Though we have said that registration is just for 750 chemical substances, the notification also requires spectrum analysis. We should have ample laboratories, ample time, ample people to get the things done. Considering India has a lot of MSMEs, we should be careful about the timeline,” said Karthik Nilagiri, Senior General Manager-Corporate Affairs, Reliance Industries Limited.

“The cost is also an important factor. While registration cost is Rs 9 lakh, the notification itself is Rs 6 lakh. Even if it is not in Schedule II, a lot will be required to be notified. So should consider the cost analysis of the entire implementation. I would also like to bring attention to polymers because per say once the monomer is converted into polymer, it can’t go back and it’s not going to impact the way monomer would impact. I would urge the Indian government to go the Korean way where they look at the polymers for safe use,” added Nilagiri.

In line with the timeline, 18 months are short not only for registration but notification, especially for small and medium companies like us, says Dhananjay Pawar, Head of Regulatory Affairs and Product Stewardship, Grasim Industries Limited.

"We have a big list of substances we are using in our different products. Most of them will go above one time use in a year. Hence, the majority of these will qualify for notification. And considering the data requirements for notification, 18 months is a very short time to collect the data. There could be company specific confidential information including downstream users who are our customers. When we are notifying this, this is I believe the confidential information. The details include our customer list and who is buying in what quantity. Secondly there is no clear idea about new customers who will join us once the notification is finished. There is no clarity on it.  Secondly there is a timeline of 180 days and 60 days for the notification. There are some substances that the government will include in schedule II and then where the 60 days window period will start. There will be few companies which might not have any substance during the window period but once it is over, they might develop a new product which might need to be registered and notified. Is there a provision on late registration or late notification? There is no clarity in this draft,” Pawar elaborated.

 Priyanka Manapure, Senior Manager (Toxicology & Study Management), GPC India shared her views on UK REACH was also a part of overall discussion.

Sharing details on chemical regulations in Turkey, Mirac Merc Pelister, Turkey Business Coordinator & Regulatory Researcher, GPC Group said, “KKDIK or Turkey REACH is a copy of UK REACH regulation. When it came into force in 2017, it was considered under the EU adaptation policy and hence, the similarity. The regulation is to determine the fate of the chemical that enters the Turkish border. It needs to be tracked until it is recycled or perished. The concerned Turkish Ministry of Environmental, Urbanization and Climate Change would want to know every step involved in the use of chemicals so as to take care of human health and environmental hazards.”

 “Pre-registration phase of the regulation lasted until 31 December 2020. After that deadline has been extended up to the end of December, 2023. During this phase, the submission of registration dossiers is required. The concerned ministry has mentioned that this deadline will not be extended. GPC in Turkey. Lead Registrant (LR) appointment started in March 2021 and in this regard the pre-registrations after 15th of February cannot be deleted. The dossier submissions and preparations have started with the Substance Information Exchange Forum (SIEFs) and LR. Individual inventory formation by potential registrants and surveys sent by LRs in some SIEFs in progress. Joint submission is ongoing in SIEFs with submitted lead dossiers,” said Pelister.

The NextGen Chemicals & Petrochemicals Summit 2022 was supported by the leading names of the industry. The platinum partner was Elliot Group.

Regulatory Knowledge Partner was GPC. Gold partners of the event included Ingenero, Premier Tech, Carbanio and Deepak Nitrite. Among the associate partners were PIP and Huntsman. The industry partners of the event included AMAI, Croplife India, and ACFI.