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Guides 10 min read Chemply Regulatory Team18 January 2026

The 12-Point Compliance Checklist to Run Before Launching a New Chemical Product

Before you ship a new chemical product into any regulated market, walk through this checklist. It catches roughly 90% of the compliance issues we encounter in customer audits and pre-launch reviews.

Why a checklist beats a vibe-check

The single most reliable predictor of whether a chemical product launch will survive its first audit is not the sophistication of the company's regulatory team — it is the existence of a written, dated, signed-off pre-launch checklist. Companies that work to a checklist catch their own issues. Companies that work from memory catch their issues during the inspection.

Treat this list as a baseline, not a ceiling. Specific product categories (cosmetics, biocides, detergents, medical devices, food contact materials) layer additional sector-specific checks on top.

The 12-point checklist

1. Full quantitative composition documented, version-controlled, and signed off by a named person. Trade-secret components disclosed at least at the substance level to the safety assessor and the SDS author.

2. Every substance in the formula checked against REACH Annex XIV (Authorisation list), Annex XVII (Restriction list), and the latest SVHC candidate list. Date, list version, and result recorded.

3. Mixture classified under CLP for physical, health, and environmental hazards using the current version of Annex I and any applicable harmonised classifications from Annex VI Table 3.1.

4. Safety Data Sheet authored in the 16-section format required by REACH Annex II, in the official language(s) of every market you intend to ship to.

5. Label carries the correct pictograms, signal word, hazard statements (H-codes), and a defensible set of precautionary statements (P-codes). Label dimensions and pictogram dimensions meet the CLP Annex I, section 1.2.1 minimums for the package capacity.

6. Poison Centre Notification (PCN) submitted via the ECHA portal where required, with the correct UFI (Unique Formula Identifier) printed on the label.

7. Packaging meets child-resistant fastening and tactile warning requirements where applicable (CLP Annex II, Part 3).

8. Transport classification (ADR for road, RID for rail, IMDG for sea, IATA/ICAO for air) checked independently of CLP classification, with the correct UN number, proper shipping name, hazard class, and packing group recorded.

9. SCIP notification submitted via the ECHA database if any SVHC candidate-list substance is present above 0.1% w/w in any article supplied.

10. Sector-specific obligations confirmed: CPNP notification for cosmetics, BPR authorisation for biocides, Detergents Regulation labelling, food contact material declarations of compliance, and so on.

11. Internal documentation pack showing who performed each check, on which date, against which version of the rule, and what evidence supports the conclusion.

12. Distribution and retailer onboarding requirements separately checked: many distributors and retailers impose their own documentation requirements (ISO certifications, supplier questionnaires, declarations) that are commercial rather than regulatory but block product release just as effectively.

Why the last point matters most

Regulators rarely expect perfection. They expect evidence of a system: a process that catches errors, dates its decisions, and can produce documentation under pressure. A short, dated note saying 'SVHC list checked against the June 2026 update, no candidate substances present, signed M. Owens, 14 Sept 2026' is the kind of artefact that turns a stressful inspection into a 20-minute conversation.

Companies that institutionalise this checklist as part of every new product launch — embedded in the stage-gate process, signed off before production starts, archived alongside the formula — measurably reduce their audit failure rate. The companies that don't, find out the hard way.

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