Product Compliance for Newly-Sourced Materials in Existing Processes

Question: How should manufacturers handle a situation where a newly-sourced material must be released to keep production running, but no conformance declaration has yet been received for the REACH Regulation, EU RoHS Directive or other applicable legislation?

Answer: Generally speaking, European regulators require evidence of an ongoing due diligence program for the REACH Regulation and EU RoHS Directive. If you can be certain your compliance process will collect data from any new supplier and lead to any necessary compliance actions, such as communication under the REACH Regulation, you are likely to remain in good standing.

However, complications may arise if the requested documentation is not made available, or if it contains unexpected information. A more conservative approach is to prevent changes to production, or to allow only limited manufacturing of a new or altered product, until all necessary information is available. If compliance documentation is ultimately not provided, a risk assessment may help companies decide what to do next. Factors to consider include the material/part risks, supplier risk, company risk tolerance, etc.

Whenever possible, compliance review and documentation should be completed before this type of change is made. Companies are in a better position to request documentation from the supplier before the new material is purchased and in use.

Article is current as of 2020-05-15.

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