EU 2016

2019 New EU 2016/425 standard for PPE Regulation

The New Approach Directive (89/686/EEC) which was a directive on the approach of the regulations of the Member States linked to Personal Protective Equipment was established. However, on 21 April 2018, it was annulled and substituted by European Union Personal Protective Equipment (EU PPE) Regulation 2016/425.

The main aim of this New Approach Directives is simply to regulate and set legislation and guidelines for various products or product divisions on the European Union market. This is attained by a number of specifications that all manufacturers have to adhere to before the products embraced by New Approach Directives can be suitably put on the market in the European Member States, the European Economic Area (EEA) and the 3 European Free Trade Association States.

Quite a number of the Directives, and in some cases directions, established common minimum safety and health objectives explicit for each product and demand the product to have the CE mark. Basically, CE marking should not be mistaken with a quality assurance code. Actually, it does not bestow evidence of third party examination, and it should never be mixed with any independent certification label of the kind given by European or international notified test bodies.

The EU PPE Regulation on the personal protective equipment.

On 21st April 2018, the EU PPE Regulation 2016/425 on personal protective equipment revoked the initial PPE. This EU PPE Regulation 2016/425 regards each specific item of personal protective equipment meant to be distributed and or put into service on the European Union market for the first time. It demands all personal protective equipment (PPE) placed on the market in the European Economic Area (EEA) to comply with the ordinance and not to compromise persons as well as properties. Accordingly, all personal protective equipment should satisfy the basic health and safety provisions and this is stipulated in the personal protective equipment’s EU Declaration of conformity.

The significant dates for the implementation:

new EU 2016

  1. The Personal Protective Equipment Directive 89/686/EEC was revoked from 21st April 2018 and replaced with the PPE Regulation (EU) 2016/425 that applied from 21st April 2018.
  2. It is required that the member Nations shall not deter the making accessible on the market commodities covered by the initial PPE Directive 89/686/EEC earlier than 21st April 2019.
  3. The EC type examination certificates given under Directive 89/686/EEC will be applicable until 21st April 2023 unless they become expired before that given date.

The scope of the new PPE Regulation.

The regulation applies to:

1). equipment invented and made to be put on or held by an individual for security against one or more dangers to that person’s safety or health;

2). interchangeable parts for devices indicated to in point (i) which are necessary for its shielding purpose;

3). connexion systems for facilities cited to in point (i) that are not worn or held by a person, that are intended to attach that equipment to another external equipment or to a secure dock Point, that is not meant to be lastingly fixed and that do not need fastening operations before use;

The exemptions to the regulation.

The Regulation does not regard to PPE:

1). particularly made for application by the armed or security forces or in the keeping or law and order;

2). made to be applied for own defence, except for PPE meant for sporting pursuits;

3). made for private application to guard against: atmospheric situations that are not of an absolute nature, water and damp during dish-washing;

4). Personal Protective Equipment on aircraft or seagoing vessels

5). headpieces or helmets and their visors for operators and passengers of mopeds and motorcycles.

CE marked under the European Union PPE Regulation 2016/425.

People who apply the Personal Protective Equipment for rendering protection against safety and health hazards must be informed that commodities can be given a CE marking under various directives and Personal Protective Equipment could be accredited under another directive and CE marked respectively. Therefore, those buying PPE need to request for proof from the supplier that the Personal Protective Equipment endorsed meets the provisions of the European Union PPE Regulation or has been endorsed under the PPE Directive and put on the market before 21st April 2019.

Who is now responsible for compliance?


 PPE directive

For the old ppe standard, the manufacturers, supplier and authorised representatives can apply to certificate for ppe. For the new PPE regulation (EU) 2016/425, the importers/distributors also can apply to new EU certificates for the PPE items. Basis on this regulation, for importer can do certificate by supplier samples.

Which company can do the new EU certificate?

Any test company that meet Europe union request can do it. Most china suppliers use Intertek, ETC or TUV such test company to apply to new EU certificate for PPE items. Because many suppliers need to change the old version certificate to EU 2016/425 from 2018, so it will need long time to get new PPE certificate, As PPE exporter, the early to get the EU certificate, the easy can get the PPE orders from clients. As one PPE suppliers in China, Anbu ppe also is doing new EU certificate for safety shoes.

The bottom line

Following the abolishment of the Directive 89/686/EEC, the New Approach Directive on PPE and the ultimate replacement by the European Personal Protective Equipment 2016/425 on 21st April 2018, there are some new PPE standards that need to be observed. Ordinarily, there is a transitional adjustment where products in compliance with Directive 89/686/EEC can be presented if put on the market before 21st April 2019. With that in mind, the new standard has to be incorporated into the marketing world for the purpose of meeting the set regulations.