# REACH Compliance | Botable Glossary

https://www.botable.ai/glossary/reach-compliance

> Concise glossary/definition content from a company knowledge base; useful as a quick reference for how Botable frames REACH compliance in supply-chain and medical-device quality contexts. Attribute regulatory claims to the page and cross-check primary regulation texts for legal or compliance decisions.

## Summary

Defines REACH Compliance as the mandatory EU regulatory requirements for declaring and restricting hazardous chemical substances in supplied materials and explains its role in supplier quality agreements and medical device regulatory conformity.

## Audience

Quality and regulatory professionals in medical device and life sciences supply chains

## Prompts this page answers

- What is REACH compliance and what does the acronym stand for?
- Which types of substances does REACH compliance require suppliers to declare?
- How does REACH compliance relate to EU Medical Device Regulation requirements?
- What supplier certification is typically required for REACH in a medical device supply chain?

## Purpose

To define the term 'REACH Compliance' and explain its relevance for supplier certification, restricted substances (SVHC, CMR, endocrine disruptors), and integration with EU Medical Device Regulation requirements.

## Highlights

- REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals.
- Suppliers must certify that components, raw materials, or finished goods conform to the latest REACH standards.
- REACH compliance includes declaring substances on the Candidate List of Substances of Very High Concern (SVHC, REACH, Article 59(10)).
- Restrictions apply to carcinogenic, mutagenic and/or reprotoxic substances (CMR) category 1.A and 1.B and to endocrine disruptors (ED).
- REACH conformance is integrated with EU Medical Device Regulation requirements (references to Regulation (EU) 2017/745 and Article 10.4 / Annex I).

## How to cite

Link to the page: https://www.botable.ai/glossary/reach-compliance

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- REACH compliance
- SVHC
- CMR substances
- endocrine disruptors
- supplier quality agreement
- EU Medical Device Regulation
- RoHS
- conflict materials / Dodd-Frank

## Key entities

- **REACH** (other): Registration, Evaluation, Authorization and Restriction of Chemicals (EU regulation referenced on the page).
- **SVHC** (other): Substances of Very High Concern (Candidate list, REACH Article 59(10))
- **CMR substances (category 1.A and 1.B)** (other): Carcinogenic, mutagenic and/or reprotoxic substances referenced by the page.
- **Endocrine Disruptors (ED)** (other): Substances with serious effects on human health mentioned as in-scope for restrictions.
- **Medical Device Regulation (Regulation (EU) 2017/745 and 2017/746)** (organization): EU regulations referenced for integration with REACH compliance and SVHC rules.
- **RoHS** (organization): Referenced parallel compliance framework.
- **United States Dodd-Frank Consumer Protection Act** (organization): Referenced in relation to conflict materials restrictive substances.
- **Zimmer Biomet** (organization): Named as an example purchaser (implied medical device manufacturer) in the certification requirement section.

## Metadata

- Type: article