Regulatory Services on REACH

Companies placing on the EU market substances, preparations, or articles, must comply under REACH with a number of obligations.

B-Lands Consulting's technical staff has an extensive experience in providing registration services and regulatory assistance with respect to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (EU REACH), as well as CLP notifications, and labelling services in compliance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (EU CLP).

In compliance with Articles 4, 8, of REACH, in some instances, a EU based REACH representative must be appointed.

Article 26 of REACH

The Inquiry is the alternate starting point of the registration process when conditions for undertaking the substance pre-registration step are no longer met.

Multilanguage Authoring

Professional services for the generation of safety data sheets (SDS/MSDS) & extended safety data Sheets (eSDS), fully compliant with the new REACH / CLP format, along with corresponding product labels.

Notification to the C&L Inventory

The CLP Regulation stipulates that all substances must be classified and labelled according to the CLP criteria from 1 December 2010 onwards and that all mixtures must be classified and
labelled according to the CLP criteria from 1
June 2015. Substances must be notified within one month from being placed on the market.

Quick SVHC Assessment

Once a substance is added to the SVHC Candidate List, the REACH Regulation imposes immediate obligations on manufacturers and importers to declare the substances if present. Article 33(1) of the REACH Regulation states that manufacturers and importers of articles (products) are required to notify their customers of the presence of any Substances of Very High Concern (SVHC) in their products exceeding 0.1% by weight and provide instructions on safe use of the product.

SVHC Notifications

Art. 7(2): Producers and importers have to notify to ECHA the substances listed on the Candidate list which are present in their articles, if both the following conditions are met: (1)The substance is present in their relevant articles above a concentration of 0.1% weight by weight. (2) The substance is present in these relevant articles in quantities totalling over one tonne per year.

Article 2(7)(b) of REACH

Article 2(7)(b) of the Regulation (EC) No 1907/2006 (REACH) and its amendment by Regulation (EC) No 987/2008 of 8 October 2008 sets out criteria for exempting substances covered by Annex V from the registration, downstream user and evaluation requirements.

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Thorough substance inventory & identification (CAS, EINECS, IUPAC naming, etc.)

Identify all chemicals placed on the market, or substances used in products (or in the production process) and, for each substance, determine its regulatory status, gather information on its properties, and assess volumes, specific uses, and concentrations.

Article 28 of REACH

Potential registrants can submit via their appointed REACH representative, certain information to ECHA (late pre-registration) and benefit when applicable, from the extended registration deadlines. Producers and importers of articles with an intended release of a substance can also submit a late pre-registration.

Registration of Chemicals

Companies have the responsibility of collecting information on the properties and the uses of substances that they manufacture or import at or above one tonne per year. They also have to make an assessment of the hazards and potential risks presented by the substance.
Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles.

When substances are excluded from the REACH registration process

The authorisation procedure aims to assure that the risks from Substances of Very High Concern are properly controlled and that these substances are progressively replaced by suitable alternatives while ensuring the good functioning of the EU internal market.

Limits for the manufacturing, use of certain substances

A restriction applies to any substance on its own, in a mixture or in an article, including those that do not require registration.
Restrictions aim to protect human health and the environment from unacceptable risks posed by chemicals.
Companies dealing with substances subject to restrictions must respect REACH provisions that may limit or ban the manufacture, placing on the market, or use of a substance.

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Traceability of compliance

B-Lands Consulting provides a REACH certificate of compliance for a specific product whether it is a preparation, a substance, or an article. The certificates provide assurance to customers that a product has been reviewed by a third party for REACH compliance and offers traceability of compliance.

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Complete dossier generation

IUCLID (International Uniform Chemical Information Database) is a software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances. This software is the key tool for companies to fulfill data submission obligations under REACH. We provide full assistance for generating complete registration dossiers under IUCLID.

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Physico-chemical, toxicological, environmental fate, eco-toxicological testing

To help companies meet the complex REACH testing requirements, we have established a global network of third party laboratories to conduct at effective costs, physico-chemical, toxicological, environmental fate, eco-toxicological and residues testing and analysis services.

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Tacking REACH onsite inspections by authorities

From May 2011 until March 2012, the national enforcement authorities inspected 1 181 enterprises covering 6 900 substances, 4500 mixutres and 4500 safety data sheets (SDSs). The majority of the inspected companies were small or medium-sized. More than half of the inspected companies were not only active as downstream users but also in additional roles, e.g. as manufacturers, importers, distributors and only representatives In total, 67% of the inspected companies were non-compliant with one or more provisions of REACH or CLP. Non-compliance was most commonly related to contraventions of (pre-)registration (REACH, 8%), notification (CLP, 15%), failure to keep information (20%) and having deficient risk management measures (12%).

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Ensuring REACH ompliance long the supply chain

In accordance with the Regulation (EC) N° 1907/2006 (REACH), a number of obligations are required from actors in the supply chain. Whereas manufacturer, importer, or downstream user, each stakeholder is required to comply with his own obligations under this Regulation. B-Lands Consulting is offering professional services for assisting companies meeting REACH Compulsory requirements through the supply chain.

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Entry point for all regulatory services related to: The European Union