REACH Regulation 1907/2006/EU, the moving target!

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals and it regulates all chemicals we use in every product.

First, every manufacturer, importer or distributor (economic operator) of any type of goods has responsibilities based on the REACH regulation in Europe. In Switzerland, the ChemRRV includes the chemical regulation of REACH, but also includes RoHS, Battery Directive, POP Directive, Packaging Directive.

The if you are a manufacturer or importer of any kind of goods, then you are a down-stream user. Your obligation is mainly to monitor the SVHC substances contained in your products and communicate this information along the supply chain. SVHC substances can be put up for authorization as per Annex XIV of REACH or even restricted (banned for certain or even all applications) as per Annex XVII of REACH. Such SVHC substances are reportable to your customers, unsolicited for B2B, on request if asked by a consumer. SVHCs, substances in need of authorization as per Annex XIV of REACH and restricted substances as per Annex XVII of REACH should be replaced using safer chemicals. If you are manufacturer of raw materials or mixtures then you have more obligations, but this is not part of this article.

On January 17th 2023, the list of SVHC, the so-called “candidate list” has been extended by 9 more substances, in total 233 substances are now on this list. The ECHA repeats this process twice a year, every January and July. We estimate that in the coming years, the SVHC list will grow to approximately 1000 substances, here you have the moving target.

But how to deal with this regulation in a pragmatic way?

1.      Gap analysis: what do you already have in place? What needs to be done?

2.      Risk based approach, not every SVHC is in your product.

3.      Keep your data up to date.

4.      Gathering and Validating supplier information.

5.      Tune your supply chain communication.

6.      Compiling sales product level declarations.

7.      Inform your customers proactively!

In the long run, it makes sense to select materials with safer additives and raw materials, mainly if your product contains or is made of plastics. By doing so, it is important not to select so-called “regrettable replacements”, e.g. additives that have the potential also to become an SVHC at a later stage.

How to select safer raw material for your plastic parts?

1.      Material selection with safer raw materials and additives

2.      Verification and validation of the new materials

3.      Project management for change-over projects

4.      Train your design engineers on Material Compliance and Safety!

Peter Pianegonda, Lead Regulatory Expert, Gradical [email protected]