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personal protective equipment

1. Technical Regulation Under The Responsibility Of The Ministry Of Labour And Social Security:

a. “Personal Protective Equipment (PPE) Regulation published in the Official Gazette dated 1/05/2019 and numbered 30761” (The basis of the regulation: Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC)

2. General Product Requirements

  1. Products within the scope of the Personal Protective Equipment Regulation must bear the "CE" marking and be placed on the market with a Turkish user manual.
  2. In order to affix the "CE" marking to the products, the necessary conformity assessment processes of the products must be successfully completed.
  3. Conformity assessment procedures are determined according to the categories of risk against which PPE is intended to protect users. Risk categories are also refer to PPE categories.
  4. The categories of risks that Personal Protective Equipment are defined as follows:
  1. Category I: Category I includes exclusively the following minimal risks; superficial mechanical injury,  contact with cleaning materials of weak action or prolonged contact with water, contact with hot surfaces not exceeding 50°C, damage to the eyes due to exposure to sunlight (other than during observation of the sun),  atmospheric conditions that are not of an extreme nature.
  2. Category II: Category II includes risks other than those listed in Categories I and III.
  3. Category III: Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following;  substances and mixtures which are hazardous to health, atmospheres with oxygen deficiency,  harmful biological agents, ionising radiation, high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C, low-temperature environments the effects of which are comparable to those of an air temperature of – 50 °C or less, falling from a height, electric shock and live working,  drowning,  cuts by hand-held chainsaws, high-pressure jets,  bullet wounds or knife stabs,  harmful noise.

 

  1. For detailed information on the categories of the products, please refer to section 20 of the document at https://ec.europa.eu/docsroom/documents/29201
  2. The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:
  1. Category I: Internal production control (module A) set out in Annex IV of the PPE Regulation;
  2.  Category II: EU type-examination (module B) set out in Annex V of PPE Regulation, followed by conformity to type based on internal production control (module C) set out in Annex VI of PPE Regulation;
  3.  Category III: EU type-examination (module B) set out in Annex V, and either of the following:
  1. Conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII of PPE Regulation;
  2. conformity to type based on quality assurance of the production process (module D) set out in Annex VIII of PPE Regulation

 

  1. A  Notified Body should be applied to for the Module B, Module C2 and Module D conformity assessment procedures for category II PPE and category III PPE.
  2. Notified Bodies: Information on the titles and registration numbers of notified bodies, including those residing in our country, can be found at https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
  3. The current list, which includes the reference numbers of the harmonised standards relevant to PPE, can be found at https://ec.europa.eu/docsroom/documents/46431 In addition, European Union Standards harmonized as Turkish Standards can be queried from https://intweb.tse.org.tr/Standard/Standard/StandardAra.aspx.

 

3. Obligations Of The Manufacturer Laid Down In The Personal Protective Equipment Regulation

  • When placing PPE on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II.
  • Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 20 or have it carried out. Where compliance of PPE with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, manufacturers shall draw up the EU declaration of conformity referred to in Article 16 and affix the CE marking referred to in Article 17.
  • Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market.
  • Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in the design or characteristics of the PPE and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by PPE, manufacturers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
  • Manufacturers shall ensure that the PPE which they place on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the PPE does not allow it, that the required information is provided on the packaging or in a document accompanying the PPE.
  •  Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in Turkish language or language easily understood by end-users.
  • Manufacturers shall ensure that the PPE is accompanied by user manual set out in point 1.4 of Annex II in a Turkish language which can be easily understood by consumers and other end-users. Such instructions and information, as well as any labelling, shall be clear, understandable, intelligible and legible.
  • The manufacturer shall either provide the EU declaration of conformity with the PPE or include in the user manual set out in point 1.4 of Annex II the internet address at which the EU declaration of conformity can be accessed.
  • Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the Ministry in which they made the PPE available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
  • Manufacturers shall, further to a reasoned request from the Ministry, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation, in Turkish language. They shall cooperate with the Ministry, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.

 

4. Obligations Of The Importer Laid Down In The Personal Protective Equipment Regulation

  • Importers shall place on the market only PPE that complies with the provisions of the PPE Regulation.
  • Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 20 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the CE marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 9(5) and (6).
  • Where an importer considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not place it on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the importer shall inform the manufacturer and the Ministry.
  • Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The contact details shall be in a Turkish language.
  • Importers shall ensure that the PPE is accompanied by user manual set out in point 1.4 of Annex II in Turkish language.
  • Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.
  • When deemed appropriate with regard to the risks presented by PPE, importers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
  • Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the Ministry in which they made the PPE available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
  • Importers shall, for 10 years after the PPE has been placed on the market, keep a copy of the EU declaration of conformity and ensure that the technical documentation can be made available to the Ministry upon request.
  • Importers shall, further to a reasoned request from the Ministry, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in Turkish language. They shall cooperate with the Ministry, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.