Sectors
Five sectors, one process.
Each sector has its own risks, standards and test pathways. We coordinate them for Switzerland and the EU — through accredited partner labs and notified bodies where required.
EN 71, hazardous substances and Notified Body
Toys
The most strictly regulated consumer good in Europe outside MDR. Children cannot protect themselves — the law makes the manufacturer responsible.
- Richtlinie 2009/48/EG
- EN 71-1
- EN 71-2
- EN 71-3
Open sector →
CPSR, CPNP and the responsible person
Cosmetics
EU Cosmetics Regulation 1223/2009 requires no prior authorisation — but it requires that all conditions are met before the product is sold.
- EC 1223/2009
- CPSR (Teil A + B)
- CPNP-Notifizierung
- UFI/ECHA
Open sector →
REACH, CLP and the safety data sheet
Chemicals
REACH reverses the burden of proof. Not the authority must prove a substance is dangerous — the manufacturer must prove it is safe. No data, no market.
- EC 1907/2006 (REACH)
- EC 1272/2008 (CLP)
- UFI/ECHA
- SVHC-Candidate-List
Open sector →
Migration, limits and the declaration of compliance
Food contact materials
The most invisible category in compliance. Packaging, containers, tableware, kitchen utensils — they touch what people eat every day.
- EU 1935/2004
- EU 10/2011 (Kunststoff)
- CH LMG/LGV
- GMP 2023/2006
Open sector →
MDR — the system shift
Medical devices
The Medical Device Regulation is the largest regulatory shift in the history of European medical technology. Treating MDR as administrative overhead misses what it is.
- EU 2017/745 (MDR)
- ISO 14971
- ISO 13485
- EU 2017/746 (IVDR)
Open sector →