REACH is Getting Some Teeth

Michael Wurzman & Heidi M. Wittenborn, RSJ Technical

REACH is starting to get some teeth, but that doesn’t mean it has to take a bite out of your bottom line! Until now many companies worldwide including many in the EU have adopted a strategy of ignoring REACH entirely as enforcement actions were focused on large volume consumer products.  Today things have changed.  The EU amended its Waste Framework Directive to include the implementation of a database to identify substances in all products made in or imported into the EU – the SCIP database ((https://echa.europa.eu/scip-database).  SCIP is the acronym for Substances of concern in articles, as such or in complex objects (products).

With the 2015 “Once an article, always an article” (O5A) decision by the European Court of Justice, the interpretation of what is an article under REACH changed.  The definition of an article went from the fully-assembled product to each component incorporated into that product.  The data for the SCIP database is for the lowest level article in a product, such as the lead frame inside an IC.  A product, such as a wire harness, is a complex object made of multiple articles.  Data is needed for each level of components in your product.

All companies within the scope of the REACH regulation are required to submit data to the SCIP database no later than December 31, 2020 for products currently being sold in the EU and those which will be introduced in 2020.  From January 5, 2021, new products cannot be introduced into the EU unless the data has been entered into the SCIP database. The reporting requirements apply to products made in the EU and to products imported into the EU.

Right now, at a minimum you must submit data to meet REACH Article 33(1) requirements.  Ultimately, you will be required to submit full material declarations (FMDs) for each article to meet the EU’s stated goal of achieving a circular economy.  An FMD lists all substances present not just those currently required to be disclosed by REACH or other regulations.

Collecting data for the SCIP data base will be challenging for many reasons.  First, the database structure is being finalized now.  The final structure of the database is expected by the end of the first quarter of 2020.

A second issue is the protection of confidential business information.  Discussions for determining what will be legitimate confidential business information in FMDs, and, therefore, allowed to be kept confidential are ongoing.  The EU is committed to protecting such information.  What we do know is this information is defined as NOT including declarable substances, i.e. those subject to regulation.

To compound the data collection challenge, the EU is committed to significantly increasing the Candidate List (SVHC list) by the end of 2020 through the European Chemical Agency’s Community Rolling Action Plan (CoRAP) (http://bit.ly/2DQKFMt).  CoRAP calls for all currently identified potentially hazardous substances to become Candidate List entries by December 31, 2020.

Given this short time frame and the unknowns surrounding which substances will be added to the SVHC list, you need to start collecting your product substance content data now.  The commonly collected certificates of compliance and reporting of current SVHCs only will be insufficient in the future.  Furthermore, certificates already collected will be obsolete.  While some leeway is expected initially, SVHCs contained will be the minimum information required for initial data entry.

To meet SCIP requirements, you will need to provide:

  • information that allows the article (product) to be identified;
  • the name, concentration range and location of the SVHC in the article; and
  • possibly other information on the safe use of the article.

The SCIP database will be accessible to customs and other EU authorities, as well as consumers and your competitors.  Authorities will be able to check for the presence of product substance data before allowing a product into the EU or being sold in the EU.  This is what will give REACH enforcement real teeth.

What You Need to Do

You need to start now gathering the data you will need to populate the SCIP database for your products.  Due to the anticipated expansion of the SVHC list, the most practical solution is to collect FMDs to minimize data recollection efforts.  (Data recollection efforts are costly and can be difficult as you exhaust your supply chain’s willingness to respond with repeated requests for data.)

Step 1 – Formulate a Plan to Collect and Manage the Data

You will need to collect more data; manage it effectively; analyze it for the information needed to comply with regulatory requirements; and create data submissions for the SCIP database.

Compliance data can be challenging to collect especially for items already in inventory or items purchased as lifetime buys.  You are going to have to go back to your suppliers on parts you may not have purchased in a while.

You need to

– Understand what data you need

– Determine the mechanism you are going to use to collect the data.

Step 2 – Collect the Data

Collect full material declarations for all materials and components used in your products.  Collecting the data includes reviewing incoming data for acceptability which means developing standards of what constitutes acceptable data.  Collecting the data may well include educating your supply chain to provide data that meets your acceptability standards.  Finally, you must continue to pursue the data until you have acceptable data for every material and component in your product.

A critical part of your data collection efforts will be your communications to your suppliers.  You must set the expectation for full FMDs while allowing for less than full declarations to be acceptable for any first attempt by a supplier to provide data.  Some suppliers will ignore requests for data in hopes that the issue will go away.  Others may refuse to supply data because they are not contractually obligated to do so.

Educating suppliers regarding the data needed and the criticality of providing it will be an ongoing challenge.  Do not expect your suppliers to get it perfect the first time around.  Also remember that your suppliers may have to reach out to their suppliers and on and on to tier N to obtain the necessary data.

Step 3 – Analyze Your Data

You need to identify which of your component parts and assemblies, if any, contain reportable amounts of SVHCs.  The reporting threshold is 0.1% of the substance against the weight of the part.  In other words, if a part weighs 10 grams and the amount of the substance present in the part is 0.01 grams, you must report this part as containing an SVHC that meets or exceeds the reporting thresholds.  Remember reporting an SVCH includes not only identifying the substance and the amount present but also exactly where the SVHC is in your product.

If you have any questions regarding the SCIP database and the required data collection and management process, contact Michael Wurzman, mwurzman@rsjtechnical.com.

 

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