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Personal Protective EquipmentRegulatory Changes

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As a global leader in the manufacturing and development of protective gloves, MAPA PROFESSIONNEL understand the importance of compliance and the need to keep customers informed. With new PPE regulatory changes in the pipeline, this brochure provides an overview of the key changes coming into effect.

The goal of this European directive is to ensure safety at work, for the user of PPE as well as for public health.

It means that a PPE must provide the required protection level, but must not jeopardize the health of the user.

To achieve this requirement PPE will be defined with a harmonized European standard. This will deal with the

protection performance of the PPE as well as the comfort and satisfaction of the user.

It also ensures free movement of the PPE through the European Union without reducing the protection level required

to avoid any distortion of competition.

The directive is old. It dates from 1989 : more than

25 years !

It is not easily adaptable to new technology. It is for

EU Member States only.

Some inadequacies and inconsistencies have been

shown during its application.

It has been transposed into national law, so the laws

governing the PPE in Europe are different in each

country.

> THE DIRECTIVE WILL BE REPLACED BY REGULATION 2016/425

The regulation applies from 21 April 2018.

The directive 89/686 is cancelled on that date.

It is for all EU citizens.

It does not require transposition into national law, so

will be the same in all European Union countries.

The CE type-examination certificate does not have an expiry date.

The batch number is not mandatory on the PPE.

The manufacturer’s address is not mandatory on the PPE.

In the instructions leaflet: Obligationto write the washing instructions.

The EC declaration of conformity is available on request.

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The EU type-examination certificate will be valid for 5 years. If there is no change of standard and PPE, the manufacturer will not be required toarrange any new tests, they will only be required to arrange administrative re-certification between 12 months and 6 months before the expiry date.

A batch number must be registered on the EPI.It is already true on most MAPA PROFESSIONNEL gloves.

The manufacturer’s address must appear on the EPI, except for gloves due to a lack of space (TBC).

In the instructions leaflet: Obligation to write the washing numbers before performance degradation.

In the instructions leaflet: Obligation to write the internet address where the EU declaration of conformity is available.

Why is PPE regulated ?All professional gloves are Personal Protective Equipmentand must today comply with the European Directive 89/686.

The main differences are as follows:

Today: Directive 89/686

Today: Directive 89/686

21/04/2018

Application of Regulation

Gloves that comply with the directive can enter the EU

Re-certification of all our gloves accordingto regulation (Duration maximum 1 year)

The CE type-examination certificate compliant with the Directive remains valid for the movement of gloves inside the EU

21/04/2019 21/04/2023 Tomorrow: Regulation 2016/425

Tomorrow: Regulation 2016/425

Why does the directive need to be revised ? The timing of regulation