The manufacturer must ensure that the PPE complies with the relevant essential health and safety requirements The requirements are met if the PPE is designed, manufactured and equipped in accordance with the relevant harmonised standards.
Where a PPE product does not have a harmonised standard setting out the requirements and test methods applicable to it, the manufacturer must provide detailed information in the technical documentation of the product concerned as to how the health and safety requirements for that PPE have been met.
Essential health and safety requirements
Essential health and safety requirements for PPE are set out in Annex II to the PPE Regulation. (PPE Regulation (EU) 2016/425, Annex 2).
The Regulation sets out the essential health and safety requirements in a general and principled manner. The Regulation does not specify the solutions to be used to meet the requirements but allows manufacturers leeway for different technical solutions.
The essential health and safety requirements of Annex II of the PPE Regulation are divided into three parts. Section 1 sets out the general requirements for all PPE. Section 2 sets out additional requirements common to several types of PPE. The requirements set out in section 2 relate to the characteristics of the product, such as the indication of the date of manufacture and expiry in the case of PPE that expire. Section 3 sets out additional requirements specific to particular risks that relate to PPE that protect against different types of hazards.
You can read more about the essential health and safety requirements in Annex 2 to the PPE Regulation (EU) 2016/425).
What is a harmonised standard?
A harmonised standard is a standard drawn up by a European standardisation organisation that has been confirmed upon the request of the European Commission in order to apply the EU product legislation.
Whereas the PPE Regulation sets out the essential health and safety requirements that are mandatory in general terms, the European harmonised standards for PPE provide the technical details, performance levels and test methods required for PPE. The use of standards is voluntary. If a manufacturer does not use harmonised standards, it must demonstrate the conformity of the product with other means.
The references of harmonised standards are published in the Official Journal of the European Union (OJEU). A list of all harmonised standards for PPE is available on the European Commission’s website.
European standards are developed openly through volunteer work in cooperation between experts from different countries. Experts from all parts of society, such as trade and industry, research institutes, consumers’ and citizens’ organisations, higher education establishments and the public administration can participate in drawing up the standards. The Finnish Standards Association (SFS) steers and coordinates standardisation in Finland.
Anyone can purchase standards. In Finland, copies of the standards can be bought from the Finnish Standards Association SFS (sales.sfs.fi).
Official Journal of the European Union
What does PPE’s presumption of conformity mean?
When PPE is designed and manufactured in accordance with the harmonised standards, it obtains a presumption of conformity. It is presumed to be compliant with the relevant essential requirements of EU legislation if:
- the manufacturer has designed, manufactured, examined and tested the product in accordance with the harmonised standards
- and the product complies fully with all the relevant harmonised standards.
The manufacturer has no obligation to manufacture the PPE in accordance with the standards, as the standards are recommendations in nature, and their use is voluntary. The requirements set in acts and decrees are mandatory, meaning that they must be followed.