India REACH regulation

India’s Chemicals (Management and Safety) Rules aims to align the country with other regions’ REACH regulation, such as EU REACH.

India has been working on their REACH regulation for almost a decade, with the fifth draft of the CMSR released on August 24 2020. However, implementing hazardous chemical rules to enhance the safety of chemical substances in industrial activity and business operations means new regulatory hoops for companies to jump through.

In this article, Expert Services Manager, Sunita Paudyal, details the REACH requirements and what they mean for multinational corporations across the value chain.

The catalyst behind India's chemical safety rules

As innovations in the chemical industry open new opportunities in the market, they also bring new obstacles to protecting our consumer products from hazardous substances. Updating requirements in line with changing needs is critical to safeguarding the health of individuals and the environment. This is especially the case in India’s rapidly evolving and growing marketplace.

According to the India Brand Equity Foundation (IBEF), India ranks as the 6th largest producer of chemicals globally, accounting for USD 178 billion. And by 2040, it’s expected to almost triple — reaching USD 1 trillion. Yet this country’s unhurried chemical regulatory developments haven’t matched the market’s fast growth pace. Enter the proposed Chemicals (Management & Safety) Rules.

In a long overdue effort to update its chemical laws (and after a long history of revisions since 2014), India issued the fifth draft of its Chemical Safety Rules in 2020. While still in the proposal stage, these rules will bridge the gap between India’s limited chemical regulations and the more inclusive ones of other regions, namely the EU REACH regulation.

India REACH regulation

There’s a theme among India’s many forthcoming EHS regulatory developments. Like its overhaul of labor legislation for a safer workplace and of environmental law for a safer world, the country also wants to revamp REACH regulations to reduce chemical risks. The plan is to do so through regulation with a broader “reach” or scope, covering Notification, Registration, or Restriction of substances.

India’s current regulations around chemical substances don’t have the same wide-scope control as REACH in the European Union, for example, but instead focus on the user level. To be on par with this European regulatory framework, India will expand its chemical safety to include requirements starting at the point of origin. This will mean implementing new regulations for these earlier stages as well as establishing authorities who will impart control over them.

Prepare for new obligations

The proposed Chemicals (Management and Safety) Rules will require companies to establish inventory — as well as mandate both Indian manufacturers and importers to provide their chemicals’ health and safety information to authorities. Such new regulations will include requirements around notification, registration, restriction, prohibition, packaging, and labeling. This goes for substances and mixtures (including their intermediates) manufactured, imported, placed, or intended to be placed on the market in the Indian Territory.

Notifications

Additionally, companies will need to notify the Chemical Regulatory Division of all existing substances manufactured or imported in quantities more than 1 ton per annum (TPA).

This should be done within the initial six-month notification period, starting one year from the date of the rules’ adoption. For any new substances introduced after the initial period, companies must complete the notification process at least 90 days prior to placing them in the Indian Territory. Companies must also update information of notified substances (e.g. the total quantity placed) by 31 January every year.

Labeling

Alongside new notification requirements come those for labeling. To match with REACH regulations, the Chemicals (Management and Safety) Rules will implement labeling requirements according to the 8th revision of GHS guidelines.

These include additional stipulations for packaging, chemical safety, and accident preparedness as well as requirements for the use of non-notified substances.

Authorities

On top of these obligations, the rules will also establish several authorities to control the production and sale of chemicals. One such agency is the Indian National Chemical Authority (INCA) — equivalent to the European Chemicals Agency (ECHA).

Additionally, the country plans to implement scientific, risk assessment, and chemical regulatory committees as well as special units to oversee and implement the provisions under the rules.

Registration

According to the new rules, manufacturers and importers that place in Indian Territory any Schedule II priority substances (or their intermediates) in quantities of more than 1 TPA will need to register them, within 1.5 years of their inclusion on the list.

Businesses will need to submit a technical dossier containing every aspect and study of that chemical, a chemical safety report, and a chemical exposure scenario like EU REACH. Once the dossier is submitted, it must go through the detailed evaluation and assessment process carried out by the Scientific Committee and Risk Assessment Committee.

India will also establish a new mechanism to assess, identify, and designate registered substances. Through it, regulators will formulate criteria to prohibit or restrict priority hazardous substances based on their level of risk to human and environmental safety. Use of restricted substances would require authorization and would be subject to additional safety requirements.

If you’re a foreign manufacturer dealing in the Indian marketplace, you’ll need to appoint an India-based Authorised Representative (AR) for this process. Just as Only Representatives in the REACH framework, ARs are non-Indian companies’ key to collaboration with Indian businesses and consumers. Your company may only register via the Chemical Safety Rules’ procedures if you’ve appointed one.

Non-compliance consequences

One of the biggest consequences for companies is the cost of non-compliance. Whether operating or placing your products on the market in India, be aware that any non-compliance with these chemical regulations can result in hefty fines of up to USD 680 per day. Fines are dependant on the quantity of the substance you’ve placed on the market and the length of time you’ve been non-compliant.

Readying your business

Aligning its chemical management laws with global standards better positions India in the global value chain. More compatibility with the needs of more markets means more comparative advantage. In the short-term, Indian chemical companies could tap into opportunities opened by current trade conflicts. Looking at the longer-term, these new Chemical (Management and Safety) Rules increase sustainability and secure shareholder value for corporations meeting them.  

Regardless of how we’ll see this broader influence pan out, it’s clear that the changing chemical regulation in India will shift our business landscape around the world. 

Businesses can begin preparing by:

• Comparing these new requirements with current processes
• Mapping out where operations are misaligned
• Making note of critical registration and notification deadlines and where they fall in the supply chain timeline
• Getting ahead on chemical technical dossiers to be ready for the upcoming registration process