REACH Registration

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. 

In REACH:

• Registration means that all manufacturers and importers must register the substance that reaches 1 tonne per year, 
• Authorisation aims to eliminate or effectively control risks from chemicals harmful to human health or the environment, 
• Evaluation stands for the review of all REACH Registration Documents and information by the appropriate authority and,
• Restriction means some substances that are restricted have a different condition and scope for Restriction.

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:

• Ensuring a high level of protection for human health and the environment through better and earlier identification of the intrinsic properties of substance mixture.
• It applies to all substances, substances in mixtures and intermediates that are manufactured, imported, placed or intended to be placed in India. 
• The Rules provide safety and procedures for the manufacture, storage, handling and import of priority substances and preparedness and management of all chemical accidents related to the priority substances.
• It is applicable to Indian manufacturers, Indian importers and foreign entities of priority substances, mixtures, intermediates and articles. 
• The Rules provide for notification, Registration, and restrictions or prohibition and labelling and packaging requirements relating to the use of substances, substances in mixtures, substances in articles & intermediates placed or intended to be placed in Indian Territory.

Benefits of having REACH Registration

Following are different benefits of obtaining this REACH Registration in India under the Chemical Regulatory Division:

• Secure access to the Indian Market by ensuring the mandatory Registration of products having chemical substances and testing of articles 
• Proof that the manufacturers, importers or AR are safeguarding human health and the environment
• To avoid regulatory fines and litigation. 
• Consumer trust in product quality and services.

Eligibility for REACH Registration 

Following businesses are eligible to notify or register under India REACH:

• Indian Manufactures 
• Indian Importers
• Indian Authorised Representatives or AR appointed by the Foreign Manufactures 

Requirements under REACH Registration 

Following are the requirements for REACH Registration as per the draft of India REACH: 

Notification 

• Companies have to notify substances manufactured or imported more than or equal to 1 tonne per year unless exemptions apply.
• The notification period will start one year after India REACH is published, and the notification window will last for six months. 
• After the notification period, the substances must be notified before placing them in the Market above 1 tonne per year.
• Data requirements include spectral data, hazard classification, uses info on downstream users, actual quantities per year, and SDS.
• Notification fee.

Annual Reporting 

• Notification must be updated annually during the first 60 days of the calendar year. 

Registration of priority Substance 

• Companies must register substances (that are listed under schedule II) manufactured or imported more than or equal to 1 tonne per year. 
• The registration deadline is until 18 months from the date of inclusion of substances in Schedule II. 
• Data requirements include information on hazards, including robust study summaries and exposure and exposure scenarios.
• Chemical Safety Reports (CRS) are required for such substances equal to or more than 10 tonnes per year.
• Joint submission is possible under these rules, but detailed rules on data sharing have not been published yet. 

Import Control 

• At least 15 days before the import of hazardous substances or substances mentioned under schedule II, more than or equal to 1 tonne per year. The importer should notify the following information:

• 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

Evaluation 

• The relevant units of the Chemical Regulatory Division (CDR) will evaluate the dossiers within one year of submission. In case any substance is found to pose an unreasonable risk to human safety or the environment, then it may lead to Restriction or Prohibition of substances or a recommendation to add to Schedule X, XI or XII of the draft of REACH India.

Restriction/Prohibition 

• Substances listed in Schedule VI, i.e., restricted or prohibited substances, must undergo authorisation before their use. 

Hazardous Chemicals

• Listed in schedules X, XI and XII
• Indian companies handling such substances subject to the following:

• Import control 
• Safety Audit Report 
• On-site or off-site emergency plans 
• Notification of industrial activity 
• Site safety report 
• Notification of all chemical accidents 

Labelling 

• Manufacturers, importers and the downstream users of products containing more than 10% w/w priority substances or hazardous substances must:

• 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

• All notifiers of Schedule II substances and hazardous substances or the intermediates and importers of articles containing schedule II substances more than 1.0% w/w must maintain and submit an updated SDS and share the same with DSUs. 

Documents 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:

• Identity of the manufacturer or importer 
• General information on the registrant 
• Identification of the substance
• Information on the manufacture and uses
• Downstream users
• Classification and labelling of the substance 
• Guidance on the safe use of substances 
• Summaries of study reports on physicochemical properties, toxicology and ecotoxicology 
• Chemical Safety Report
• Other required Documents as per the quantities produced or imported per year.

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 Documents 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.