Overview of REACH Registration
REACH is a European Community Regulation on chemicals and their safe use. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. It focuses on improving the protection of human health and the environment through better and earlier identification of the intrinsic properties of chemical substances. Transitional periods are granted under the REACH Regulation to conduct or perform comprehensive registration tasks. To get the benefit of the transitional periods, the manufacturer or importer must pre-register a substance.
The Government of India has drafted and released by the Ministry of Chemicals and Fertilisers a European-style regulation on a chemical substance, i.e., Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH) Rules, similar to the European Union's REACH Legislation. Under this Rule, the existing and new chemical substances manufactured, imported or used within India are required to be notified, registered, and reported under certain circumstances by manufacturers, importers or authorised representatives. India's new draft for regulation of Chemical substances is named Chemicals (Management and Safety) Rules, commonly referred to as "India REACH". The new Chemical (Management and Safety) Rules, or ICMS Rules or CMS Rules, replace the existing Manufacture, Storage & Import of Hazardous Chemicals (MSIHC) Rules, 1989 & Chemical Accidents (Emergency Planning, Preparedness, and Response) (CAEPPR) Rules, 1996.
The National Chemical Authority (INCA), similar to the European Chemicals Agency (ECHA), is given charge of all actions related to notification, Registration and restrictions or prohibition and labelling and packaging requirements related to the use of substances, mixtures and intermediates placed or intended to be placed in Indian Territory.
Objectives and Scope of REACH
The objectives and scope of the REACH are as follows:
Benefits of having REACH Registration
Following are different benefits of obtaining this REACH Registration in India under the Chemical Regulatory Division:
Eligibility for REACH Registration
Following businesses are eligible to notify or register under India REACH:
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Requirements under REACH Registration
Following are the requirements for REACH Registration as per the draft of India REACH:
- Annual Reporting
- Registration of priority Substance
- Import Control
- Name and address of consignee in India
- Port of entry
- Mode of transport from the exporting country
- Name and quantity of priority or hazardous substance
- Relevant product safety information, including SDS
- Substances listed in Schedule VI, i.e., restricted or prohibited substances, must undergo authorisation before their use.
- Hazardous Chemicals
- Import control
- Safety Audit Report
- On-site or off-site emergency plans
- Notification of industrial activity
- Site safety report
- Notification of all chemical accidents
- Bear levels as per the schedule XVII
- Packaged as per the Rule 34
- Use hazard statements, pictograms, signal words and precautionary statements as per the GHS Revision 8
- In English and Hindi
Necessary Papers or Technical Dossier required for REACH Registration
The technical dossier contains all the information and data on the substance to be registered and information on risk management.
Article 10 and Annex VI of the REACH Regulation/Rules set out the minimum information to be provided in the technical dossier, which includes the following:
Procedure for REACH Registration
All manufacturers, importers and Authorised Representatives who are placed or intend to place a priority substance in quantities greater than 1 tonne per year in the Indian Territory have to register the substance within one and half years of its inclusion in Schedule II of the India REACH Rules. However, in a case where the chemical is used in fewer quantities than 1 tonne per year, then Registration is necessary but not mandatory. A technical dossier is a must to be submitted for REACH registration.
Registrants also conduct tests for the purpose of Registration following the testing methodology or protocol. The tests must be conducted in NABL-accredited or GLP-certified laboratories.
The complete process of Registration is as follows:
- The first step towards REACH Registration is Notification, i.e., manufacturers and importers have to notify their substances. A notification number and a REACH Notification Certificate are granted to the one who notifies their substances (notifiers).
- The priority substance notifiers prepare all relevant necessary papers and a technical dossier for obtaining REACH Registration.
- For REACH Registration, the notifier has to submit a technical dossier and registration fee to the unit of the Chemical Regulatory Division (CDR).
- On receipt of the same, the appropriate authority conducts a preliminary check to ensure that the Registration is incomplete; the Division requests that the Registrant/notifier submit additional information within 60 days to complete the dossier.
- When all the required and relevant information is submitted to the satisfaction of the unit (appropriate authority), then the Registration is accepted, and the registrant of such substance is assigned a registration number along with a registration certificate in the prescribed form.
Pointers to be taken into consideration related to the REACH Registration are as follows:
- Those who have obtained REACH Registration for a substance must update a technical dossier and other data submitted with the Registration to reflect any change or revision in the information that affects hazard and risk management.
- Any manufacturer, importer, or authorised representative with REACH Registration of a substance may make an agreement with other manufacturers, importers or Authorised Representatives of the same substance to jointly register the substance. However, the joint Registration must comply with all obligations imposed on an individual registration under Chemicals (Management and Safety) Rules.
- Registration is required for the intermediate substances listed in Schedule II of the Rules.
- All notifiers of a substance/intermediate listed in Schedule II or hazardous chemicals are required to update the safety data sheet and share the same with the substance's downstream user.
- Whoever places the substances listed in schedule II in quantities more than 10 tonnes per year in the Indian Territory must conduct a chemical safety assessment & submit a chemical safety report at the time of REACH Registration or notification.
- Whoever places priority substances less than or equal to 10 tonnes and more than 1 tonne per year in the Indian Territory must submit an exposure scenario at the time of REACH Registration.
- The unit of the Division (CRD) reviews the available data on substances to determine if they pose an unacceptable risk to human safety or the environment during varied usage. If the unit believes the risk posed by the use of the registered substance is significant, it can recommend Restriction or prohibition on the use of the such substance.
Frequently Asked Questions
Followings are the units of the Chemical Regulatory Division (CDR):
- Chemistry unit
- Toxicology unit
- Chemical safety and accidents unit
- Packaging and labelling unit
- Techno legal unit
- Priority substance unit
- Information technology unit
- Socio-economic unit