EU REACH

REACH registration requires companies to submit safety data and risk management information to ECHA for substances manufactured or imported into the EU above specified tonnage thresholds. REACH restriction (Annex XVII) limits or bans certain substances, mixtures, or articles to protect health and the environment. Restrictions apply regardless of tonnage and can include outright bans or conditions of use.

Companies must ensure the substance is not used or placed on the EU market in ways that violate the restriction conditions. If the substance is permitted only under specific conditions, companies must confirm compliance with those conditions (e.g., concentration limits, permitted uses, labeling or packaging requirements). Non-compliance can lead to enforcement actions, market withdrawal, or fines.

Yes, REACH Annex XVII may include exemptions or derogations for specific uses of restricted substances. These are typically outlined in the restriction entry and can vary depending on the substance and its intended application.

Some restrictions permit certain uses under conditions, like industrial processes or scientific research, while others apply only if concentration limits are exceeded.

Unlike RoHS, there is no mechanism for individual exemption applications. Companies must engage in the restriction process, often through industry associations, to seek relief for specific uses. By monitoring ECHA and Commission work programmes, public calls for evidence, and Annex XV restriction proposals, they can:

– Submit technical data on alternatives, socio-economic impacts, and exposure control to support derogations or higher concentration limits.

– Advocate for clearly defined derogations (e.g., “exclusively industrial use under closed conditions”) or time-limited transitional provisions.

Both Annex XIV and Annex XVII are critical components of the EU REACH Regulation, but they serve distinct purposes and have different compliance requirements. 

Annex XIV addresses Substances of Very High Concern (SVHCs) that pose serious risks to health or the environment, aiming to phase them out unless companies obtain authorisation to use them post “sunset date.” 

In contrast, Annex XVII lists restricted or banned substances due to their hazardous properties, covering a broader range of chemicals. 

For compliance, companies under Annex XIV must apply for authorisation from ECHA, demonstrating risk control or socio-economic benefits that outweigh the risks. Those under Annex XVII must comply with the restrictions as outlined in the Annex (e.g., bans, concentration limits, or labelling requirements). No authorisation is required, but they must ensure their products meet the restrictions or reformulate them.