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Your Guide to Managing REACH and SVHC Across the Global Supply Chain
The EU REACH regulation is the European Union’s principal regulatory framework for managing chemical substances. It is in force in 28 member states and directly affects more than 500 million people in the EU. Adopted on 18 December 2006, it sets out requirements for the control of chemicals throughout the EU. While some provisions came into force on 1 June 2007, the regulation was implemented in phases, spanning a period of more than 10 years.
The broad intent of the REACH regime is to create a single, comprehensive, overarching governmental oversight of all new and existing chemicals, subject to qualification exemptions. The scope includes the entire lifecycle of chemicals including their design and production.
The last of three major registration deadlines under REACH was 31 May 2018. From that date on REACH’s “No Data, No Market” clause under Article 5 has been in full effect. All substances in scope will be subject to registration and the lengthy process that it entails before they can be placed on the EU market.
The REACH registration deadline of 31 May 2018 applied to companies that manufacture from within the EU or import from outside the EU in low volumes ranging from 1 tonne to no more than 100 tonnes a year. Pre-registration of the substance is also a requirement. The impact of companies selling through their downstream supply chain into the EU will be discussed below.
Simultaneously, under REACH’s Title VII authorization scheme, Substances of Very High Concern (SVHC) have been continuously added to the candidate list every six months since 2008. The addition of a substance to the list is the first step in the authorization process and can lead to a possible sunset date after which the substance is forbidden on the European market.
The Impact of REACH
REACH affects all companies that fit into one of two categories:
- Those directly doing business in the EU
- Those selling through their downstream supply chain into the EU
REACH applies in principal to all chemical substances employed in the EU, including those used in industrial processes and also those used as part of consumers’ day-to-day lives. Examples include cleaning products, paints and articles such as clothes, furniture and electrical appliances.
REACH requires and encourages communication up and down the supply chain, all the way to the consumer level, and it makes manufacturers responsible for their suppliers.
Failure to work up and down the supply chain can carry a risk—loss of business. A SVHC can be given a sunset date which, barring the granting of an authorization, will lead to a ban of its use in the EU. It is also possible to have restrictions or authorizations for a specific use, sometimes on a temporary basis, as safer alternatives are sought.
In the long run, communication up and down the supply chain in a timely manner ensures the most hazardous substances are substituted with less hazardous ones before any loss of business. If a manufacturer or distributor is unable to get required information from their supplier, they may decide to stop purchasing from that supplier. This possibility can motivate many suppliers to be compliant before any EU member state REACH enforcement action can result in an even greater loss. The goal once hazards have been identified and prioritized is to test and substitute substances appropriately.
Private and international suppliers, distributors, importers and others have often been required to field a massive number of information requests from the companies subject to REACH. Companies often do not have visibility into their own supply chains beyond their direct relationships so these requests entail a great deal of work, potentially requiring support to be compliant.
Verisk 3E™ offers supply chain solutions to enable the collection, validation, enrichment and contextualization of supplier data required for continuous REACH and REACH SVHC supply chain compliance.
REACH Registration Requirements
REACH required all duly pre-registered substances manufactured or imported in the EU annually, within the 1-100 metric tonne range, to be registered with the European Chemicals Agency (ECHA) by 31 May 2018. Since that date has passed, all substances in scope will be subject to registration and the lengthy process that it entails before they can be placed on the EU market.
Registration is a process that has associated cost, time and required collaboration to reduce animal testing. Once registered, each substance registration comes with a unique ECHA assigned number held by the company that registered it. The number in full or in part is for use on the REACH compliant Extended Safety Data Sheet (eSDS) and used to prove registration compliance to the supply chain. A registration number is required for each legal entity.
Some manufacturers are willing to share their registration number with their customers strategically, or share it after passing on the cost of the registration. In sharing registration–however, there are more requirements for information up and down the supply chain for things like use and amount imported into the EU.
Downstream users may then have their own restrictions on whom they can purchase from if they do not seek and own the registration themselves. For example, they may find themselves restricted to buying only from suppliers that offered to share their registration and to whom they have exchanged use data.
Verisk 3E’s Regulatory Consulting team can work closely with you to identify, analyze and address your organization’s registration and other REACH requirements.
REACH Substances of Very High Concern
Registration of existing and new substances is not the only component of REACH compliance. Special attention must be given to the growing and evolving list of REACH SVHC. The SVHC candidate list grows every six months, and suppliers of articles must supply information for the safe use of articles containing a SVHC with 0.1 percent weight by weight (w/w) or more.
EU consumer inquiries regarding the presence of an SVHC in a product must be answered within 45 days. Companies should immediately gather and validate supply chain data to prepare for consumer demand as well as for immediate customer reporting obligations. Article 33 requires any supplier of an article containing a SVHC on the 'Candidate List' in a concentration above 0.1 percent weight by weight (w/w) to provide the recipient of the article with sufficient information to allow safe use of the article.
Manufacturers combining articles into a complex product of assembled articles have been given clarification from the courts. The 0.1 percent weight by weight (w/w) threshold applies to an original article which is a component within a more complex assembly of articles.
Tight timeframes and the addition of new SVHC bi-annually make it likely a manufacturer will require a supplier to make a full material disclosure (FMD) via an Ingredient Disclosure request.
Challenges to compliance include communicating with suppliers, fielding requests, changing contracts, making public statements regarding REACH and educating suppliers as to why this information is necessary. It is especially challenging to do this across time zones in different languages and in cases where proprietary information is at stake. Supply chain solutions from Verisk 3E can streamline this exchange of information, making it seamless to the customer and supplier.
How Verisk 3E Can Help
3E Connect™, streamlines the exchange of material, product and supplier information throughout the global supply chain. Verisk 3E can stand as your single source of truth for supply chain compliance, creating an intelligent and actionable knowledge base for the origins, makeup and compliance status of your substances, components and products. Our team collects, validates and manages compliance documentation regarding EU REACH, enabling you to assess requirements and declarations of SVHCs required by Article 33.
Verisk 3E’s expert Authoring Services team offers exposure scenario authoring services to alleviate the burden of producing lengthy and complex REACH-compliant eSDS documents for customers. We can author eSDSs for both substances and mixtures. We offer support for the latest industry-sector Safe Use Mixture Information (SUMI) approach and templates, expertise with the universal Lead Component Identification (LCID) methodology and a complete, ready-to-use, high-quality Exposure Scenario Phrase Library containing phrases translated into European Economic Area (EEA) languages.
To address REACH requirements, our Regulatory Consulting Services staff can serve as an extension of your own team, reducing the burden on your internal resources, decreasing the workload of compliance personnel and bridging any gaps in regulatory knowledge. We can leverage our industry-leading content, expertise and products to develop practical, effective compliance programs designed specifically to meet the needs of your organization.
You can learn more about REACH and SVHC in the following resources:
REACH (Registration, Evaluation and Authorization of Chemicals) No. 1907/2006
REACH ECHA Resource Page
REACH European Commission Resource Page
REACH ECHA Registration
REACH ECHA Registered Substance
REACH ECHA Only Representative
REACH ECHA Authorization
REACH ECHA Candidate List for Substances of Very High Concern (SVHC) Obligations
REACH ECHA Candidate List for Substances of Very High Concern (SVHC) for Authorization List
REACH ECHA Annex XIV List of Substances Subject to Authorization
REACH ECHA Restriction
REACH ECHA Annex XVII Restrictions on MFG Placing on the Market
ECHA Classification, Labelling and Packaging (CLP) Regulation
REACH ECHA Persistent, Bioaccumulative and Toxic (PBT) and very (vPvB)
ECHA Substances of Concern In articles as such or in complex objects (Products) (SCIP)
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