Yes — every EU cosmetic needs a signed safety assessment. Who may write it, what the assessor asks you for, what it costs, and the records that make it cheaper.
Short answer: if you sell cosmetics in the EU — even four jars of balm at a Saturday market — every product needs a safety assessment before it goes on sale. The CPSR, the Cosmetic Product Safety Report, is that assessment written down, and it lives inside your Product Information File. There is no handmade exemption. This guide is about the part most makers actually ask: who writes it, what they need from you, and what you can prepare yourself.
Annex I of Regulation (EC) No 1223/2009 splits it in two. Part A is the safety information: the full formula, the ingredient data, stability, microbiological quality, packaging, exposure. Part B is the assessment itself — a qualified assessor's reasoned conclusion that the product is safe as you make and sell it, with their signature on it.
Not most of us. Article 10(2) requires a university qualification in pharmacy, toxicology, medicine or a similar discipline. Unless you hold one, you cannot self-assess — you hire an assessor. Part A is different: it is your data, and the more of it you hand over organised, the less time the assessor bills gathering it.
Prices vary by assessor, product complexity and how ready your paperwork is — per-product fees spanning tens to a few hundred euros are common, and missing data is the usual cause of the higher end. Variants of one product (same base, different fragrance) are often assessed together for less than separate products would be.
Everything in Part A rewards tidy records: exact recipes with percentages, supplier documents filed per ingredient lot, batch records that show consistency. That is bench discipline more than science — and it is the part a tool can carry for you. Alchemis keeps recipes, ingredient documentation and batch records in the shape an assessor asks for them; the assessment itself always belongs to a qualified human.
Advisory, not legal advice — and never a substitute for the assessment itself. The regulation text is public at eur-lex.europa.eu (Regulation (EC) No 1223/2009, Article 10 and Annex I).
Educational, not legal or safety advice. Check current official sources before you act on it.
Batch records, lot numbers, ingredient labels and IFRA checks are built into the workshop, so the guide you just read becomes a habit, not a chore.