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Directive 89/686/EEC was replaced by Regulation (EC) 2016/425

Directive 89/686/EEC was adopted in 1989 and reflected the requirements for the safety of personal protective equipment (PPE). With the development of technologies in the field of PPE requirements of this document were replaced by Regulation (EC) 2016/425. The new document contains updated rules for manufacturers. What are they? Let's figure it out together.

To begin with, the requirements of the previous Directive remain unchanged. The new ones are added to them. For example, according to Directive 89/686, mandatory product labeling should include:

  • Identification of the manufacturer.
  • Model identification.
  • EN136:1998 standard number and year.
  • Mask class.
  • Parts exposed to time must have a production date. If they cannot be marked, this information must be placed in the user manual.
  • Replacement parts must be clearly marked. If they cannot be marked, this information must also be placed in the user manual.
  • Marking should be clearly distinguishable and long-term.

In addition, European Regulation 2016/425 requires the application of additional markings, including the type, serial number, batch number or other identification element, the name of the manufacturer, the registered trade name or trademark, and the postal address of the manufacturer. All contact information should be provided in a language understandable to the end user and market surveillance authorities. If it is not possible to apply the above additional markings, the manufacturer must ensure that this information is placed on the packaging or in the accompanying documentation.

Starting from April 21, 2019, references to the new Standard should be updated in the following documentation:

• Data sheets.

• Declarations of conformity available on the official website.

• The user's manual.

In general, the new European Regulation obliges the manufacturer of protective equipment to:

• ensure that goods comply with EU law;

• assess the conformity of each type of product;

• keep technical documentation and the EU Declaration of conformity for 10 years;

• create user-friendly and safety instructions;

• provide information about the manufacturer on the packaging and accompanying documents;

• conduct security testing and maintain a register of identified problems and inconsistencies. If problems and inconsistencies are identified, notify the special authorities.

Thus, the main difference between the two documents is that the responsibility for each step in the supply chain of PPE is described more clearly.



Consider the frequently asked questions regarding the introduction of the Regulation (EC) 2016/425:

1) What if the purchased products are certified under the previous Directive 89/686/EEC?

- You can continue to use it until the expiration date indicated on the package.

2) What changes will occur with the CE certificate for the product?

- It will be valid until April 20, 2023, unless otherwise specified or unless changes have been made to the product itself.

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