01
EU market access for chemicals.
Registration under REACH is a precondition for placing a substance on the EU market above registration tonnage thresholds — "no data, no market" is the regulation's explicit principle.
Product & Regulatory
REACH — chemical compliance, on file.
Substance identification, SVHC screening, registration strategy, and supply-chain data programmes aligned to the EU's REACH regulation and ECHA's evolving expectations.
What it is
The EU regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals.
REACH is the EU regulation (EC) 1907/2006 governing chemicals placed on the European market. It imposes obligations on manufacturers, importers, and downstream users across four broad streams: registration (of substances manufactured or imported above one tonne per year), evaluation (of dossiers and substances), authorisation (of Substances of Very High Concern listed in Annex XIV), and restriction (of specific substance uses listed in Annex XVII).
Beyond these, REACH Article 33 obliges suppliers of articles containing SVHCs above 0.1% weight-by-weight to communicate that information to downstream recipients and, on request, to consumers. The SCIP database requires the same information to be submitted to ECHA for articles placed on the EU market. UK REACH, post-Brexit, operates a parallel regime with its own registration and SVHC obligations.
Who needs it
Chemical manufacturers, importers, formulators, and article producers.
Chemical manufacturers, importers into the EU, formulators and mixture producers, producers of articles (non-chemical products) placing them on the EU market, downstream users with specific identified uses, and non-EU manufacturers whose Only Representative (OR) registers on their behalf. Indian chemical, pharmaceutical intermediate, and specialty materials manufacturers serving EU customers routinely face REACH obligations — either directly via an OR, or indirectly through customer requests for Article 33 / SCIP disclosures.
Benefits
What a well-built BIFMA system earns you.
02
Article 33 readiness.
Article 33 requests from customers are routine. Organisations prepared to respond quickly with validated supply-chain data protect customer relationships and avoid supply-listing delays.
03
SCIP compliance.
Producers and importers of articles containing SVHCs must submit data to the SCIP database. Enforcement varies by member state but is tightening.
04
Authorisation pathway.
For substances moving to Annex XIV, early engagement on authorisation applications or substitution strategy protects continuity of use.
05
Restriction foresight.
New Annex XVII restrictions (microplastics, PFAS subsets, bisphenols) are coming. Supply-chain substance visibility lets you anticipate rather than react.
06
Shared platform with RoHS.
Supply-chain substance data collected for RoHS largely supports REACH SVHC screening. Integrated programmes are materially more efficient than siloed ones.
Requirements, in outline
What the standard actually asks of you.
Obligations depend on role and substance tonnage. Manufacturers and importers of a substance at or above one tonne per year must register; higher tonnage bands (10, 100, 1000 tonnes) trigger additional data requirements including ecotoxicology and longer-term safety studies. Non-EU manufacturers register through an EU-based Only Representative. Registration dossiers are submitted through ECHA's IUCLID platform and are evaluated for compliance.
Article 33 requires producers and importers of articles containing an SVHC above 0.1% w/w to communicate sufficient information to the recipient to allow safe use, including at minimum the name of the substance. The SVHC candidate list is updated by ECHA and contains well over 200 entries. SCIP database submission is required for articles on the EU market. Annex XIV (authorisation) imposes a sunset date after which use is prohibited unless authorised; Annex XVII (restriction) prohibits specific uses of specific substances above specific concentrations.
Our approach
Five stages, from discovery to certificate.
01
Role & obligation mapping
Identify the organisation's role under REACH — manufacturer, importer, downstream user, article producer — and map corresponding obligations.
02
SVHC screening
Screen products and supply chain against the current SVHC candidate list. Identify Article 33 exposure and SCIP submission obligations.
03
Registration strategy
Where substance registration applies, scope the dossier, engage Only Representative and consortia where cost-sharing is available, and manage data-gap closure.
04
Supply-chain programme
Build a sustainable supplier-engagement programme — declarations, IPC-175x / IEC 62474 data exchange, escalation for non-responsive suppliers.
05
Authorisation & substitution
For substances approaching Annex XIV sunset or Annex XVII restriction, evaluate authorisation application economics against substitution investment.
Timeline & investment
Honest ranges, not placeholder pricing.
SVHC screening and Article 33 readiness for a focused product family typically runs eight to twelve weeks. Substance registration — especially at higher tonnage bands — runs considerably longer, with data generation (eco-tox, toxicology studies) often measured in months or years; consortium-led registrations shorten this significantly for organisations willing to share data.
Fees depend on product complexity, supply-chain depth, and whether registration is in scope. ECHA fees, consortium fees, OR fees, and testing fees are separate and are often the largest cost component in registration work.
Frequently asked
Questions we answer on most BIFMA calls.
Directly, no. Obligations sit on the EU legal entity (importer, Only Representative, EU manufacturer). Practically, customers in the EU will demand REACH-compliant evidence from non-EU suppliers, and failure to provide it effectively closes the market.
Article 33 obligations trigger when an SVHC is present above 0.1% weight-by-weight of an article. The ECJ clarified in 2015 that this threshold applies at the individual article level (the "once an article, always an article" interpretation), not the overall product.
Cosmetics substances are covered under a separate Cosmetic Products Regulation; REACH registration obligations apply to the substances as manufactured or imported, not to the cosmetic product formulation itself. Medicinal substances are out of REACH registration scope but subject to separate medicinal regulation.
Post-Brexit, UK REACH operates as a parallel regime for substances placed on the GB market. Substances already registered under EU REACH are not automatically registered under UK REACH — deadlines for transitional registrations have been extended multiple times and current deadlines should be checked against HSE guidance.
Enforcement varies by member state. Several authorities have begun routine checks against SCIP submissions; non-submission is treated as a breach of the Waste Framework Directive. Submission is low-cost and low-risk; non-submission carries growing enforcement risk.
Related services
Often pursued alongside BIFMA.
RoHS
Material declarations, testing coordination, and technical documentation for RoHS compliance.
Learn moreCE Marking
Directive selection, technical file preparation, testing liaison, and declaration of conformity.
Learn moreISO 14001
Identify aspects, control impacts, and demonstrate environmental due diligence to every stakeholder.
Learn moreGet a readiness assessment for REACH.
Half a day with a senior consultant, a clause-level gap report, and a candid timeline. No commitment beyond the assessment itself.