"It is important for the chemical industry to understand the Indian Chemicals Management and Safety Rules (CMSR) which currently is in draft form but is expected to get notified later this year," says Shisher Kumra, Founder & Executive Director, Global Product Compliance Group (GPC) India.

“The regulation has been under discussion since 2010 with various background studies, consultations, and discussions done at many stages. The main activity of the current draft started in 2019 and since then there are five draft versions that have come into the public domain. Based on the suggestions, a lot of improvements have been done and we believe that the best version will get notified," says Shisher Kumra. 

Among various suggestions in the draft CMSR is the setting up of the National Chemical Authority that will have three key organs, a Steering Committee with 16 government officials; Scientific Committee with 10 members and 5 co-opt members; and Risk Management Committee 8 members and 4 co-opt members. However, the major challenge is the 18 months product registration deadline that is way too short for prioritizing regulation. The deadline is the same, be it for 1 ton, 1,000 ton or greater than that. That needs to be addressed besides the early setting up of authority and creation of guidance documents to ensure enough time for compliance. Updated safety data sheets for all chemicals must be kept ready before the regulation is notified," added Kumra.

Kumra along with other experts discussed the various aspects of draft CMSR in detail at the ‘Indian CMSR Technical Session’ as a part of ‘NextGen Chemicals & Petrochemicals Summit 2021’ organized by Indian Chemical News from 7-8 October, 2021. The discussion was moderated by Dr. Jayachandran Nair, CEO, GPC India.

“Galaxy Surfactants’ customer base ranges from small lady beauty parlour to big global FMCG companies. Therefore, CMSR will have a huge impact on our line of products and business. In the case of products that are exported by us to other countries, we have to just follow the regulations for only those products. But in CMSR, we need to comply with the rules for every chemical we are sourcing and importing, be it intermediates or mixtures that we are manufacturing for even domestic consumption. So, the workload is humungous but we are not waiting for it to be notified, rather working on ensuring its compliance. CMSR will also have its bearing on textiles, leather, and other allied sectors that are dependent on chemicals. Given the onus on safety of human beings, we must actively participate in ensuring the implementation of the regulations,” says Avila D’Souza, Leader - Value Acceleration, Galaxy Surfactants Limited.

“For Reliance, compliance is foremost. It is highly focused on ensuring safety before we do any kind of business. Given that countries in Europe and elsewhere have introduced good chemical regulations, we were awaiting for the same in India. Therefore, it is good to see the draft CMSR and we welcome it wholeheartedly. I believe that India with a huge population has to follow the precautionary principle to check the side effects rather than waiting for chemicals to affect people and then react accordingly. We have a lot of polymer, refinery, textile, and other products besides upstream and downstream people and supply chain. We have sub sectors, polyesters, chemicals, petroleum products and for each sector we have a team of two people. One will look at the technical aspects and other at the business side besides procurement. We have a complete team to ensure that we comply well with EU REACH, Turkey’s regulations etc. Likewise we are ready to follow the CMSR also. While there might be a cost for compliance but safety comes on the top for us,” says Karthik Nilagiri, General Manager - Corporate Affairs, Reliance Industries Limited.

Challenges Galore

Listing out the challenges and expectations, Nilagiri added further, “Managing the compliance within 18 months of the registration of molecules is going to be a tough task. In case of dosage evaluation, authorities might take one year. While the earlier draft said 180 days for compliance, the current draft has made it 210 days. If there are any gaps in evaluation, we have additional 10 days but what if there is a requirement of animal testing or other toxicity tests? It will become a complex problem for companies if there are more issues. What is alarming is that CMSR mentions suspension of registration if not complied within the timeline. Therefore, we request the government to consider addressing the issue on a case to case basis and provide an additional timeline as there could arise the need for toxicity or animal studies which might take time.”

“The clarification must come on the timelines in a few specific cases. There are limitations as preparatory study itself takes 6-7 months and testing laboratories don’t have empty slots. These issues must be addressed in the current draft. Again a company might be ensuring compliance but that is not enough as the entire supply chain compliance is equally very important. Though it is not explicitly mentioned in the CMSR draft, we can imply that it is for each stakeholder in the supply chain. This adds to the burden of the companies in the beginning but in the longer run will streamline the sector,” mentions Kumra.

Talking about the challenges as a downstream user, D’Souza says, “The rules are very clear to us. Company shall not buy any intermediate or mixture which will not comply with the rules. Second is that if your chemical is not notified by the supplier, it is the duty of downstream users to notify it. Sometimes it is very difficult to source a chemical and when you find a supplier, it is equally difficult to ensure that it has met all the regulations. In case of confidential uses, there is a responsibility of notifying it, increasing the burden on the industry. Preparing safety data sheets is a big task and again adds to our burden. Because of compliances, the cost of chemicals and raw materials will also increase.”