To operate a manufacturing plant operating within the European Union (EU), adhering to the REACH regulation is not just a legal obligation, it is also a crucial aspect of maintaining sustainable and responsible business practices.
REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals and it is a comprehensive European Union regulation that is aimed at ensuring that chemicals are used safely and at protecting human health and the environment.
Compliance with REACH is essential for manufacturers if they want to avoid hefty fines, maintain market access, and uphold their reputation.
Let’s take a look at the essential REACH requirements for manufacturers to ensure compliance.
1. Registration of Substances
The first and foremost requirement under REACH is the registration of substances.
This means that manufacturers are obliged to identify and register all chemicals that are produced or imported in quantities of one tonne or more per year.
The registration process involves three main things:
- Data Collection: Gathering comprehensive information about the properties, uses, and hazards of the substances. This includes physical-chemical properties, toxicological data, and environmental impact.
- Safety Assessment: Conducting a thorough safety assessment to evaluate the risks associated with the use of the substances.
- Dossier Submission: Submit a registration dossier to the European Chemicals Agency (ECHA) through the REACH-IT portal. The dossier includes the gathered data and safety assessment.
Failure to register substances can result in significant penalties and the prohibition of the manufacture or import of those substances.
2. Evaluation of Substances
After registration, the ECHA evaluates the submitted dossiers to ensure compliance with REACH requirements. The evaluation process includes:
- Dossier Evaluation: ECHA checks the completeness of the dossiers and may request additional information if needed.
- Substance Evaluation: For substances that are of concern, ECHA will conduct a more in-depth evaluation to assess the potential risks to human health and the environment. Manufacturers may need to provide further data or conduct additional tests.
Manufacturers must be prepared to respond to ECHA’s requests in a timely and accurate fashion to avoid delays and ensure compliance.
3. Authorisation of Substances of Very High Concern (SVHCs)
Certain substances are classified as Substances of Very High Concern (SVHCs). These would generally require authorisation before they can be used or marketed at all.
SVHCs include:
- Carcinogenic, mutagenic, or toxic for reproduction (CMR) substances.
- Persistent, bioaccumulative, and toxic (PBT) substances.
- Very persistent and very bioaccumulative (vPvB) substances.
- Substances of equivalent concern, such as endocrine disruptors.
Manufacturers using any of these substances must apply for authorisation and be able to demonstrate that the risks are adequately controlled or that the socio-economic benefits outweigh the risks.
In each case, alternatives should be considered, and a substitution plan may be required.
4. Restriction of Hazardous Substances
REACH imposes certain restrictions on the manufacture, marketing, and use of certain hazardous substances.
These restrictions are listed in a separate annex (Annex XVII) of the regulation and can apply to specific substances, mixtures, or articles.
Manufacturers must ensure that restricted substances are not used beyond the specified limits and must comply with any conditions or prohibitions imposed.
5. Communication and Information Sharing
Effective communication along the supply chain is essential in REACH compliance. Manufacturers must:
- Safety Data Sheets (SDS): Provide comprehensive Safety Data Sheets for all hazardous substances and mixtures. SDS must be updated regularly and shared with downstream users.
- Substance Information Exchange Forums (SIEFs): Participate in SIEFs to share data and reduce testing costs. Collaboration within SIEFs helps to fulfill registration requirements efficiently.
- Downstream User Communication: Inform downstream users about safe handling practices, exposure scenarios, and any restrictions associated with the substances.
Transparent communication goes a long way in ensuring that all stakeholders are aware of the risks and can take appropriate measures to manage them.
6. Substance Identification and Analysis
Accurate identification and analysis of substances are crucial for compliance. Manufacturers must ensure that they identify chemicals correctly, use validated analytical methods to determine the composition and purity of substances and maintain the traceability of substances throughout the supply chain.
7. Record-Keeping and Documentation
Manufacturers must maintain detailed records and documentation for a minimum of 10 years after the last use of the substance. Records should include:
- Registration dossiers and evaluation correspondence.
- Safety assessments and risk management measures.
- Authorization and restriction compliance documentation.
- Communication records with supply chain partners.
Proper record-keeping facilitates audits, and inspections, and ensures continuous compliance with the regulation.
Complying with the REACH requirements is essential for manufacturers to operate legally within the EU and to safeguard human health and the environment. It is important to ensure that one is informed and proactive in chemical management as the regulations are constantly changing and substances are being added to the list. This will continue to be a critical aspect of successful manufacturing operations. You can find more information here.
