Registration, Evaluation, Authorization and Restriction of Chemicals

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It is a Regulation of European Union. I have tried to compile some relevant information. 

REACH is concerned with the production and usage of chemicals, and their impacts on humans and environment. This has come into force from June 2007, with complete implementation in phases over the next decade. 

All companies manufacturing or importing chemical substances of one tonne or more per year in the European Union will be required to register these substances with European Chemicals Agency in Helsinki, Finland (ECHA). REACH is applicable to all chemicals imported or produced in EU. ECHA will manage the technical, scientific and administrative aspects. 

European Chemicals Agency will need to be notified of presence of Substances of Very High Concern (SVHC) in articles, if they are present above certain tonnage and concentration thresholds. These SVHCs can have potential negative impacts on human health or the environment. 

Some SVHCs will be subjected to new controls called 'authorization'. European Chemicals Agency can deny authorization, making continued use illegal. 

What is REACH? 

REACH is designed to integrate the control of production, import and use of chemicals in Europe. This will create an information based system which ensures that useful safety information gets to those using the chemicals. It replaces the network of 40 or so regulations. 

The primary change in REACH is that the main responsibility for chemical safety is clearly placed on the chemical producer or importer into the Europe. It does not lie on public authorities or downstream users. 

It fulfills two key objectives:

1) Lays out the regulatory system for the management of chemicals in the Europe. Information requirements for all substances should pass both up and down the supply chain. 

2) Describes a phased process to overcome the lack of data on existing chemicals. This includes a series of deadlines, according to tonnage, to register existing chemicals’ information. Information on all existing substances manufactured, or imported in the Europe, in 1 tonne or more per year should be available. The timeline for this is within 11 years of REACH entering into force.  

How will REACH work? 

REACH requires all manufacturers and importers of chemicals must identify and manage risks related to the substances they manufacture and market.  

For substances produced/imported in quantities more than 1 tonne/year/company a registration is required. This must be submitted to the European Chemicals Agency (ECHA). The Agency will then check that:

> Compliance with the Regulation and evaluation of testing proposals.

> Ensure that the testing of the chemical substances will not cause in unnecessary testing on animals.

> As required, ECHA may select substances for a broader evaluation to investigate substances of concern.

> An authorization system to ensure that substances of very high concern are properly controlled.

> ECHA can impose restrictions on the manufacture or use of substances causing an unacceptable risk to human health or environment.

> EU members’ authorities are responsible for enforcing through inspections & penalties for non-compliance.

Key Components of the REACH Regulation 

Registration The process by which chemical substance manufacturers and importers are obliged to send a registration dossier containing safety data to a ECHA on substances handled in quantities of above one tone/year.For usage of 10 tonnes or more per year of a substance a chemical safety report (CSR) is required. Also (material) safety data sheet (SDS) is required.  

Evaluation Evaluation is a process by which registration dossiers are examined. There are two types of evaluation with different aims at Dossier Evaluation, Compliance Check & Substance Evaluation. The evaluation process will ensure that reliable and useful data is made available to the relevant bodies by the Agency. 

Authorization For substances of very high concern (SVHC), an authorization is required for their use and their placing on the market. These substances are considered to have hazardous properties of high concern.

Restrictions Chemicals which pose unacceptable risks to human health or the environment and need to be managed on a Europe-wide basis may have production or specific uses legally restricted through this process. 

Classification and Labeling REACH creates an inventory of classification and labeling of chemicals. Industry must submit the classification and labeling of all substances to a central, public database.The European Commission has introduced Globally Harmonised System of Classifying and Labelling Chemicals (GHS) for this purpose.  

Information Flow Most of the information generated by REACH will be publicly available, including the main database of substances and properties and the classification and labeling database. 

IT Enabling Tools 

IUCLID 5 - A tool for chemical information managementInternational Uniform ChemicaL Information DatabaseIUCLID is the essential tool to capture & store, submit, and exchange data on chemical substances stored according the format of the OECD. It also helps in preparation of dossiers for submissionIt allows to entry, management, storage and exchange information on intrinsic and hazard properties of chemical substances. It uses the Harmonized Templates developed by Organisation for Economic Cooperation and Development.  

REACH-IT - A paperless system for easy access to chemical informationREACH-IT is the central IT system providing support for REACH. It’s an online software tool to achieve the following goals:

> Submit registrations and share information on chemicals online.

> Allow companies to easily sign-up online.

> Submit dossiers and other required information on chemical substances to the Agency.

> Review at any time the status of their dossiers, search information and obtain contact details of other companies that have data on the same substance.

> This means an easy and quick paperless administrative process.

> To ensure improved transparency of chemicals data.

> Smoother administration.

With REACH-IT central workflow system, the Agency and Member States authorities can evaluate and review dossiers on chemical substances online.  

Business Challenges: Additional registration cost of 100,000 € per substance (average). Uncertainty around market value vs. costs and risks. Impact on companies’ strategy: portfolio adjustment, M&As Business. Vast amount of product data to be managed and prioritized (Which substance to register when and by whom?). Uncertainty on timely registration activities at suppliers and customers end. Significant uptake in information sharing and enforced communication along the supply chain. Higher operational costs, redundant work and delayed dossier submission in case of inefficient collaboration. Tracking & monitoring of REACH program status and activities difficult due to lack of process integration and data harmonization. 

IT Challenges: Registration Process Support. Solution for Substance Volume Tracking to define reporting timeline. Integrate Substance Volume Tracking into Shipping Process. Enhance Material Safety Data Sheets. Integration in existing infrastructure.

Which SAP Solutions are Involved?

SAP EH&S – Environment, Health & Safety

SAP GRC – Governance, Risk & Compliance

SAP GTS – Global Trade Services