A set of new ‘Recommendations for Use’ (RfU) sheets in support of the PPE Regulation (EU) 2016/425 was proposed by the European Coordination of Notified Bodies in the field of Personal Protective Equipment (PPE). RfUs are technical sheets for coordination of a common position of the Notified Bodies on PPE regulatory issues. Following discussion and approval by the PPE Working Group, RfUs are published on the European Commission website.
Small Business Standards (SBS) would like to express comments on the draft RfU PPE-R/00.057. Such RfU is about the validity duration of test reports under the PPE Regulation. The document aims at clarifying the maximum time from the date of issuing of a test report for its use in a new EU-type examination certificate, proposing the following solution:
Question:
Which would be the maximum time from date of issue of a test report to be useful for a new EU-type examination?
Solution:
No more than five years/
SBS is seriously concerned that limiting the duration of the validity of a test report will cause unnecessary costs for SME manufacturers, while having no positive impact on the safety of products. It should be noted that the PPE Regulation introduced a limit of 5 years to the validity of EU-type examination certificates. However, this does not in any way affect the limit of validity of test reports, whose maximum time of validity is not defined by the PPE Regulation. It is clear that if:
- 1. the design and/or manufacture of the PPE has not changed (i.e. no change in product design/specification, raw materials/components, production method and system of production control);
- 2. none of the applicable essential health and safety requirement(s) in the legislation of reference has/have changed; and
- 3. the European harmonised standards has not changed, test reports remain valid.
This is the reason why SBS proposes the following wording for RfU PPE-R/00.057:
Question:
Which would be the maximum time from date of issue of a test report to be useful for a new EUtype examination?
Solution:
A maximum time limit for the validity of a test report cannot be defined. Test reports remain valid as long as the manufacturer has not modified the product type, where ‘unmodified products’ means no change in product design/specification, raw materials/components, production method and system of production control, and the reference standards have not changed and continue to meet the essential health and safety requirements.
SBS believes that this proposal reflects the spirit of the PPE Regulation to avoid unnecessary additional tests or examinations which would have the only effect of creating unnecessary administrative burden and increasing costs of certification.
Finally, SBS considers that clarity is needed about which type of product alteration(s) imposes on the manufacturer the obligation to undergo full or partial testing procedures in order to obtain a new EU-type examination certificate. Because RfUs are widely recognised as a valid solution to get a common view on regulatory matters, SBS proposes the drafting of another RfU to achieve a common position on this specific issue.
