What is REACH Certification?
REACH Certification is an abbreviation for Registration, Evaluation, Authorization, and Restriction on the use of Chemicals. This regulation (EC 1907/2006) was brought about in the European Union in 2006. This Certification is crucial for chemical products and substances that are manufactured and imported to the European Union. REACH Certification regulates the law of the chemical industry on global standards.
After the implementation of REACH, all the industries that manufacture and import chemicals into the European Union have to ensure to register the chemicals. However, this would only apply to companies that produce chemicals in quantities of more than one tone per year. REACH Certification was brought out to improve environmental protection standards and reduce the number of hazardous substances introduced into the environment.
The primary authority for REACH certification is the European Chemicals Agency (ECHA) based in Helsinki, Finland. This Certification would be relevant where EU companies and Non-EU companies import their chemicals into Europe. Hence, companies outside the EU will also be affected by this regulation.
Who Regulates REACH Certification?
The primary regulatory authority for REACH Certification is the ECHA. This was brought out when the European Commission drafted a white paper on the chemical strategies used within the EU. When the European Committee implemented this whitepaper, the institution required the need for regulation for Chemicals entering into the EU.
The European Parliament approved this white paper, which came into force in the year 2007. This regulation (EC 1907/2006) is introduced within EU. Another regulation that would be relevant here is the CLP Regulation (Classifying, Labeling, and Packaging) of Chemicals. This legislation has got international recognition along with the REACH certification.
Materials which Come under REACH Certification
The REACH certification would apply to all entities that are present in the supply chain. The following materials would come under the specific classification as per the REACH:
A substance can be understood as a specific chemical element. Certain compounds would also come under the definition of a substance. These elements may be used in the process of manufacture of certain chemicals (example: Formaldehyde). The substance will include all the components such as purities, raw materials, and impurities, which are used for the manufacture of the finished product. Solvents would not come under the classification of substances, as a solvent can be separated from the product without making any significant changes to the product.
The mixture can be understood as a combination of two or more substances to produce a particular product or solution. Such mixtures will include the combination of a different form of mixtures to produce products such as paints and inks. However, a substance that is used for forming a particular mixture may not be required to be registered if it does not fall within the scope of Reach. However, the reach requirement is for mixtures which cross the tonnage of 1 ton/year.
An article is considered in the process of manufacturing, that has some form of physical design. Such articles would include toys, textiles, clothes, and other accessories. If a mixture or substance is used in the article's production, and if such mixture or substance comes within the registration criteria of REACH certification, then the substance or mixture must be registered.
Entities under REACH Certification
Under the REACH Registration process, all companies within the supply chain framework play a crucial role. Hence a company needs to understand the main role it plays for the process of registration.
under Article 3(9) of the Regulation, a manufacturer can be understood as an entity or a natural person engaged in manufacturing substances within the EU. Article 3(8) defines manufacturing as the process of production in the natural state.
under Article 3(11) of the Regulation, an importer is understood as an entity or a natural person who is involved in conducting imports within a country. Article 3(10) defines the process of imports as the introduction of goods and products through the EU customs department.
under Article 8 of the regulation, an only representative can be understood as a legal entity established within the EU to carry out work for the Non-EU Manufacturer. The only representative is appointed either by the manufacturer or producer who has operations outside the EU.
- Downstream User
under Article 3(13) of the regulation, a downstream user is an entity that is not considered as a manufacturer or an importer. However, the downstream user is considered an entity that uses the substance or the mixture to carry out services or other professional work. Under Article 3(24), use can be understood as the use age, storage, and consumption of the material for a particular process.
under Article 3(4) of the regulation, a producer is an entity that just carries out the process of assembling the article. The article must be assembled within the EU for the entity to be considered as a producer.
under Article 3(14), the distributor is understood as a legal entity that places the substance or mixture in the market. Only the process of distribution happens through the distributor.
A supplier would include all the above categories of entities that combine the materials (substance or mixture) and place it in the market.
It is crucial to understand the role played by an entity in the process of the supply chain.
Eligibility Criteria for Reach Certification
- The entity should be classified under Reach Certification for the application.
- A manufacturer or importer or chemicals must produce more than 1 tonne per annum.
Procedure for Registration of Substances under Reach Certification
There are specific pre-registration deadlines under reach which have to be adhered to by the applicant. The pre-registration period for substances is 01 December 2008, and this would be applicable to phase-in substances, which is 1 tonne or more than 1 tonne.
The respective deadlines for substances for the pre-registration process are 31 May 2018. If substances are not registered with the respective ECHA, they would not be processed and allowed within the EU. Phased-in substance is understood as meeting the criteria as per the registration dossier. This can be an already existing substance which has been analyzed as per the EHCA.
Substances that are manufactured and imported in the EU depend on the respective tonnage capacity of the chemical. The following tonnage capacity is required when it comes to chemical substances:
- Tonnage which is equal to or greater than 1000 tonnes the registration must be carried out before 1 December 2010;
- Tonnage which is equal to or greater than 100 tonnes the registration must be carried out before 1 June 2013; and
- Tonnage, which is equal to or greater than 1 tonne, the registration must be carried out before 1 June 2018.
For a tonnage capacity of more than 10 Tonnes, the manufacturer or importer must get a Chemical Safety Assessment (CSA).
Analysis of the Substance
Before the substance is given for the registration process, the applicant must understand the properties present in the substance. Information is usually given in Annexure VI and Annexure-VII of the Regulation.
Information on Substances
When the applicant (manufacturer or importer) is submitting the information; the chemicals composition must be documented and provided during the registration dossier. The following information must be provided regarding the substances:
- Information regarding the characteristics of the substances.
- Any form of hazardous properties that are shown in the substance.
- Understand the requirement for the hazardous nature of substances for the process of risk assessment.
Types of Chemicals
the Chemicals can be divided into the following:
- Physiochemical Hazards
- Toxicological Hazards
- Environmental Hazards
Required Information as Per Annexure VI
As per Annexure VI of the Reach Certification, the following information has to be provided regarding the substances:
- Information of the applicant;
- Information on the substances of the products;
- Information on the manufacture and the use of a different form of substances;
- Information on the health and safety standards for a different form of substances; and
- Information such as the amount of toxic exposure or harmful exposure as per the tonnage requirements ( 1 tonne to 10 tonnes).
Establishing Chemical Identity
The applicant or the registrant must ensure to find out the chemical identities of the specific substances. The following information must be provided by the registrant when establishing chemical identity:
- Name of the substance that is used in the chemicals;
- IUPAC Name;
- CAS Number;
- EC Number; and
- Structural and Molecular Analysis which is used in the Chemical.
However, if it is not possible to provide the information in the registration dossier, the same must be mentioned in the information sheet.
The below table represents the standard information which is required:
Criteria of the Substance
Non Phase In substances which are produced greater than 1 tonne per year.
Phase in Substances which are produced greater than 1 tonne per year or the criteria specified in Annexure III
Phase in Substances, which are produced greater than 1 tonne per year. These substances do not meet the required criteria as present in an Annexure III.
Annexure-VII and Section 7 which would apply to physiochemical properties
Substances which are more than 10 tonnes per year.
Annexure VII and Annexure VIII
Substances which are more than 100 tonnes per year.
Annexure-VII and Annexure VIII. This would also include the testing data and other information which is present in Annexure IX.
Substances which are more than 1000 tonnes per year.
Annexure-VII and Annexure VIII. This would also include the testing data and other information which is present in Annexure IX and X.
If the above research cannot be conducted as per the requirements of Annexure-VII to X then the same must be provided in the technical dossier.
Information for Registration Dossier
The Registration Dossier would comprise of the Technical Dossier and the Chemical Safety Report. The technical dossier would comprise of the following:
- Information on the substance;
- Information on the manufacturer or the importer;
- Nature, Classification and How the substance has been labelled;
- Research and Study which is carried out on the chemicals;
- Health and Safety Guidance;
- Proposals for further testing of the chemicals; and
- Request if the information provided requires being confidential.
Chemical Safety Report (CSR)
CSR is required if the volume of the tonnage exceeds more than 10 tonnes. Any applicant can make their information confidential when the chemical safety report is carried out. This requirement will be according to Article 119 of the regulation.
Chemical Safety Assessment Process (CSA)
In the next step, the CSA is carried out to determine the risk present in the chemicals. This is one of the final steps when it comes to registering substances to reach certification. The following assessments are carried out in this process:
- Hazard Assessment Procedure- Where the hazard is characterized. Once this is characterized, it is documented in the registration dossier.
- Exposure Assessment Procedure- This would be dependent on a different form of scenario.
- Characterization of Risk- This requirement is needed according to Article 14(4) of the EU regulation.
Preparation of the Dossier
The ECHA can conduct an Inquiry. An inquiry on both Non-Phased-In Substances and Phased-in Substances is required to be carried out. If the data or information wants to be shared, the registrant must inquire about the exchange of information through the mode of data sharing. For non-Phased-in substances, data sharing is possible, but only after the ECHA conducts an inquiry.
Once the inquiry is conducted, information on similar chemicals and substances will be shared with the registrant as a part of the REACH certification process.
For Phased-in Substances, a SIEF (Substance Information Exchange Forum) is conducted where the registrants will have to participate in the forum for a specific exchange of information. This will increase the amount of data that is shared between the applicants.
Joint Submission is possible if different manufacturers make different substances
Compliance has to be maintained under Reach IT and IUCLID for Reach Certification. All the information in the technical dossier would be submitted under the requirement of the IT registration.
Submission of Registration Dossier
Once the registration dossier is submitted under reach certification, the ECHA will prepare a completeness check comprising technical evaluation and financial evaluation.
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