 "Handy tips for SMEs to adhere to EU's REACH regulation")
In the first part, we discussed the evolution of REACH and offered useful guidelines to make REACH registration easy. Here, we will explain the nitty-gritties of REACH registration process from SMEs perspective and also what REACH means to Indian chemical manufacturers.
Around 25,000 REACH registrations and over 3 million CLP notifications have already been submitted. By the 31 May 2013, 3,215 companies submitted 9,084 registration dossiers to ECHA. Since the start of REACH in 2008, a total of 6,598 substances have been registered. ECHA will provide the final 2013 registration outcome in early September 2013.
ALSO READ: Nearly two-thirds of companies failed to comply with REACH or CLP provisions: ECHA
Tips for SMEs supplying chemicals to Europe
Small and medium-sized enterprises (SMEs) benefit from fee reductions under both the REACH and CLP Regulations, depending on their size as a medium-sized, small or micro enterprise. Before declaring an SME size category in REACH-IT, companies need to make sure that they are familiar with the relevant SME definitions. The EU Commission Recommendation 2003/361/EC is the sole authentic basis for determining the conditions regarding qualification as micro, small or medium-sized enterprise.
For Only Representatives (ORs), the pertinent assessment of whether the fee reduction for SMEs applies shall be determined by the relevant data of the enterprise that is represented by that OR.
The European Commission has informed ECHA that it amended the REACH fee regulation and asked for immediate introduction of the new fees, which will benefit SMEs. The changes came into effect on 22 March 2013.
Companies should take into account following things when assessing the company size:
Action begins for Indian chemical manufacturers
Majority of Indian chemical manufacturers have appointed ORs under REACH to comply with the regulation, few large companies are using their EU subsidiary as OR or EU importer, and some companies continues to rely on their EU importers for REACH compliances.
ALSO READ: REACH: Making the compliance process foolproof for EU regulation
References:
The author is the Business Head – Regulatory Affairs, Dynamic Orbits Adviosry Pvt Ltd (the Indian interface of Finland-based REACHLaw), and a core member of a strategic committee formed by Chemexcil to draft ‘Indian chemical management program/Indian chemical inventory’.
Around 25,000 REACH registrations and over 3 million CLP notifications have already been submitted. By the 31 May 2013, 3,215 companies submitted 9,084 registration dossiers to ECHA. Since the start of REACH in 2008, a total of 6,598 substances have been registered. ECHA will provide the final 2013 registration outcome in early September 2013.
ALSO READ: Nearly two-thirds of companies failed to comply with REACH or CLP provisions: ECHA
Tips for SMEs supplying chemicals to Europe
Small and medium-sized enterprises (SMEs) benefit from fee reductions under both the REACH and CLP Regulations, depending on their size as a medium-sized, small or micro enterprise. Before declaring an SME size category in REACH-IT, companies need to make sure that they are familiar with the relevant SME definitions. The EU Commission Recommendation 2003/361/EC is the sole authentic basis for determining the conditions regarding qualification as micro, small or medium-sized enterprise.
For Only Representatives (ORs), the pertinent assessment of whether the fee reduction for SMEs applies shall be determined by the relevant data of the enterprise that is represented by that OR.
The European Commission has informed ECHA that it amended the REACH fee regulation and asked for immediate introduction of the new fees, which will benefit SMEs. The changes came into effect on 22 March 2013.
Companies should take into account following things when assessing the company size:
- Always consult the Finance – Accounting – Legal department before declaring the company size to your OR or REACH-IT accounts
- Extra attention to the linked/partner companies - need for consolidated accounts
- ECHA requires the registrant to provide the information within 21 calendar days from request issuance to provide the correct supporting documents
- If you fail to provide ECHA with sufficient documentary evidence supporting the SME category, your company will be charged the balance to the fee applicable to your company’s accurate size as well as the corresponding administrative charge
- Non-payment of invoices resulting of the SME verification will have severe legal consequences including revocation of the registration
- Companies should perform electronic SME test to verify their status: http://smetest.uwe.be/
Action begins for Indian chemical manufacturers
Majority of Indian chemical manufacturers have appointed ORs under REACH to comply with the regulation, few large companies are using their EU subsidiary as OR or EU importer, and some companies continues to rely on their EU importers for REACH compliances.
ALSO READ: REACH: Making the compliance process foolproof for EU regulation
Under REACH regulation only non-EU manufacturers can appoint OR, at times it is difficult for non-EU traders and distributors on how they should proceed if their EU customers demands for REACH compliance, as they cannot appoint OR. Such cases demand expert opinion on case by case basis to figure out if solution exists in both short and long-term.
Since the original pre-registration period is over, many companies are still relying upon their EU customers REACH compliances and finding difficult to add new direct customers in EU as late pre-registration is no longer valid after appointment of OR. For such cases, compliance under REACH is possible through inquiry route followed by registration.
Gagan Kumar
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All acquisitions, de-mergers plans must obtain legal advice on how it effects regulatory compliances in the country of transaction.
All exporters of chemicals to EU region are required to comply with REACH. Ministry of Commerce supports the REACH-compliance needs of Indian chemical companies through Chemexcil (the Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council), which has been undertaking lot of strategic initiatives to help large and MSME Indian chemical sector on various regulatory matters.
Chemical industry will continue to face such regulatory compliance challenges, good strategy planning must for sustainable regulatory compliance. Organisation structure, responsibilities should be well defined, develop internal project team, identity right service provider to address rapid chemical regulatory requirements.
References:
- http://echa.europa.eu/ (ECHA, Finland)
- http://www.reachlaw.fi/ (REACHLaw, Finland)
The author is the Business Head – Regulatory Affairs, Dynamic Orbits Adviosry Pvt Ltd (the Indian interface of Finland-based REACHLaw), and a core member of a strategic committee formed by Chemexcil to draft ‘Indian chemical management program/Indian chemical inventory’.