Conformity assessment

As of April 21, 2018, conformity assessment of PPE is based on meeting the requirements of Regulation (EU) 2016/425 of the European Parliament and of the Council. This regulation is directly effective and will not be implemented by any Czech regulation. They are supplemented only by Act No. 90/2016 Coll., Which gives the possibility of possible national amendments. Government technical regulation no. 21/2003 Coll., Which was repealed by government regulation no. 63/2018 Coll. The transition to the new regulation has several deadlines, the basic date is 21 April 2018, when the certificates issued under the new (EU) regulation have been applied. The issue of certificates pursuant to Government Regulation No. 21/2003 Coll. New products certified under the old regulations can still be placed on the market until 21 April 2019. During this period, manufacturers should also review their documentation for the new Regulation and issue a new EU Declaration of Conformity on this basis. Valid certificates issued pursuant to Regulation 21/2003 Coll. Directive 89/686 / EEC will be applicable until 2023. The condition is that the product and the relevant harmonized standards should not be changed. The basic principles of PPE conformity assessment do not change significantly.

The manufacturer or importer is obliged to place only a safe product on the market. It issues an EU declaration of conformity as a result of the conformity assessment process, the various variants of which, depending on the level of potential hazards associated with the use of the product, are listed in that Regulation. In most cases the basis for issuing the Declaration of Conformity is a third party certificate, which is designated as a “Notified Body” in the Regulation. It is an independent institution meeting the prescribed requirements and notified (notified) to the European Commission.

Technical requirements for PPE

The technical requirements for PPE, referred to as ‘Essential Health and Safety Requirements’, are set out in the extensive Annex II to Regulation (EU) 2016/425.

It is a characteristic of the Regulation that the essential requirements are formulated relatively broadly and strictly avoid setting specific values or limits. Indeed, a regulation, as a binding piece of legislation, cannot be amended as often as to allow technical developments to be monitored in specific values.

Exact values, limits, test procedures and other data corresponding to the basic requirements are specified by harmonized Czech technical standards. These standards are not binding, but if the PPE characteristics are consistent with them, the essential requirements of the binding government regulation are considered to be met. The official list of harmonized standards is published in the ÚNMZ Journal and is continuously updated. These are Czech technical standards transposing European standards published as harmonized in the Official Journal of the EC. The list of harmonized standards on the European Commission’s website can be found here or at the bottom of the page. Like the BHSR, the list of standards harmonized in the Czech Republic is the same as that used in the European Union. Continuous implementation of European standards for PPE into the system of Czech technical standards is dealt with by Technical Standardization Committee TNK No. 3. “Personal protective equipment”.

Classification of PPE

Personal protective equipment (PPE) is a wide range of products that are very diverse in terms of the risks they protect against. It would not be appropriate to have equally demanding requirements for the assessment of a filter that protects against toxic substances, the failure of which is a direct threat to the user, and for gardening gloves.

Depending on the degree of potential danger associated with the use of the product, PPE is divided into three categories. Their specification is given in Annex I to Regulation (EU).

The first category includes PPE protecting against minimal risks such as surface mechanical injuries, weakly aggressive cleaning agents, contact with objects below 50 ° C, sunlight (sun glasses) or weather conditions that are not of an exceptional nature.

The third category includes exclusively risks that can cause very serious consequences, such as death or permanent damage to health, for example on substances and mixtures dangerous to health, hot environments with effects comparable to those of air at least 100 °C and cold environments (-50 °C and below), falls from a height, sawing with a chainsaw or harmful noise.

The remaining personal protective equipment, which by its nature do not meet the definition of the first or third category, is classified in the second category.

The classification of PPE into individual categories is primarily a matter of the manufacturer, resp. importer. In case of doubt, the notified body concerned may of course be consulted, but the outcome of the consultation is not binding. The decisive factor is the assessment of the Czech Trade Inspection Authority.

Conformity assessment procedures

Different conformity assessment procedures are prescribed by Regulation (EU) 2016/425 for individual categories of PPE (meaning compliance with the essential requirements).

For category I personal protective equipment, internal production control as set out in Annex IV to Regulation (EU) (Module A) shall be used. The manufacturer shall draw up the technical documentation itself, assess the conformity and take measures to ensure that it is maintained during manufacture.

The notified body carrying out the EU type examination referred to in Annex V to Regulation (EU) (Module B) must participate in the assessment of the PPE category II and issue an EU type examination certificate if the product complies with the requirements.
The manufacturer or his authorized representative may have the conformity assessment carried out by any notified body in the EU. The list of notified bodies under Regulation (EU) 2016/425 is here.

EU pre-market type examination is also required for category III PPE. However, since these are products used at high risk, the manufacturer or importer must also ensure that they are kept under review at least once a year. At its option, it may choose to verify type-conformity based on internal production control along with supervised product checks at random intervals according to Annex VII to Regulation (EU) (Module C2) or type-conformity based on quality assurance of the manufacturing process VII of Regulation (EU) (Module D). The manufacturer is responsible for carrying out the checks. Without annual protocols from regular inspections it is not possible to place PPE category III on the market.

The notified body must ask the manufacturer or the authorized representative to carry out the check. Notified bodies may notify the Czech Trade Inspection (CTI), which carries out market surveillance, if it suspects that controls are not carried out.

EU declaration of conformity

The EU declaration of conformity must be drawn up by each manufacturer or authorized representative of personal protective equipment, regardless of their category. This declaration must be attached to the product manual or must contain the Internet address where the EU declaration of conformity can be obtained. A model EU declaration of conformity is given in Annex IX to the Regulation. The graphic design of the EU Declaration of Conformity, represented by the CE marking affixed to the product, is also provided to users – see below.

The EU declaration of conformity shall be based on the technical documentation as defined in Annex III to Regulation (EU) 2016/425. Manufacturers who have already issued the EC Declaration of Conformity according to the repealed Regulation 21/2003 Coll. it must review its documentation and issue, no later than 21 April 2019, a new EU declaration of conformity, whether or not they have a new certificate.

For PPEs of the second and third categories, the technical documentation must also include the EU type-examination certificate or a valid EC type-examination certificate (which shall not be later than 21 April 2023). In the case of the third category, the method of control must also be established and the resulting reports on the annual checks carried out by the notified body must be available. For products with a valid EC type-examination certificate, checks will already be carried out according to modules C2 or D in the new Regulation (EU).

The validity of the EU declaration of conformity is not limited. Only when there are changes that may affect the performance of the PPE in terms of the essential requirements must a new declaration be issued. It goes without saying that the technical documentation on the basis of which the declaration is issued must be complete and updated. For PPE of the third category, this also means periodic reports by the notified body of the checks carried out.

CE marking

Before placing the product on the market, the EU manufacturer issues a declaration of conformity. At the same time, it is obliged to affix the CE marking on the product, which serves all other customers and users as an expression of conformity with the essential requirements of the Regulation (EU). For category III PPE, the CE marking shall be accompanied by the number of the notified body that checks.

PPE requirements on the EU website

Information on conformity assessment of PPE in the European Union can also be found at:

http://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment/index_en.htm

Comment:

All of the above information is to be understood only as a professional opinion – in no way an interpretation of a government order or law to which only the court is competent.