Questions & Answers
Do standards change, and must I update my technical file or re-certify?
Yes, standards do change, and whether you must update your self-certification, technical file, or approvals depends on the region and the nature of the standard update. Generally, products already on the market are not retroactively targeted unless a severe safety hazard emerges, but new production batches or major standard shifts require action.
European Union (EU):
- Standards change: Frequently, especially harmonized standards under EU directives and regulations (like the GPSR or RED).
- Action needed: If a harmonized standard is updated and the presumption of conformity changes, you must review your product against the new limits. For self-certification (EU Declaration of DoC), you do not automatically re-certify units already sold, but new production batches must align with the revised standard, and you must update your Technical Documentation and EU Declaration of Conformity to reference the new standard version.
United States (US):
- Standards change: Regulatory bodies like the CPSC or FCC periodically update rules or test standards.
- Action needed: Under the Consumer Product Safety Commission (CPSC), existing general-use product certifications do not require periodic re-testing unless there is a material change to the product design or manufacturing process. However, if a new mandatory standard or eFiling rule takes effect, new imports/production must comply with the updated criteria.
Canada:
- Standards change: Health Canada and bodies like the CGSB update safety and labeling requirements (e.g., cosmetic or chemical updates) on regular review cycles.
- Action needed: When a standard or regulation changes (such as mandatory fragrance allergen disclosures), Health Canada typically provides a transition period. You must update your technical records, compliance files, and product labels before the transition deadline ends to legally continue distribution.
