PPE regulation with production in China

Personal Safety Equipment (PPE)

Compliance with PPE regulation for production in China

From disposable gloves to bulletproof vests, personal protective equipment covers a wide range and is a thriving market where good business can be done. However, when importing items of personal protective equipment (PPE) from China, as with domestic production, the PPE regulation must be observed.

Since 2018, the PPE Regulation has replaced the PPE Directive and has bindingly regulated the requirements for products that serve as personal safety equipment. If you want to import protective products from the following use groups, there is a high probability that they must comply with the PPE Regulation:

• Protective equipment in the commercial sector
• medical area and health service
• protective articles for leisure or sport

The experts at Agentur Frisch will be happy to advise you on the question of whether the item you are importing from China falls under the PPE regulation.

The 3 protection classes of the PPE regulation

Depending on the degree of protection, the regulation divides articles of PPE into three graduated categories. Different regulations apply to the various categories as far as import and sale in Germany (and the EU) are concerned. To ensure compliance with the PPE regulation when produced in China, you must meet the conditions of the respective protection class.

The protection classes are:

• Category 1 – light protection

Category 1 protective equipment protects against minor superficial mechanical injuries, contact with hot surfaces up to a maximum of 50 °C or normal weather conditions.

Examples:

• Sunglasses
• Cooking aprons
• Gardening gloves

• Category 2 – Miscellaneous and medium protection

Category 2 protective equipment includes all products that do not fall into category 1 or 3.

Examples:

• water wings, swimming aids
• Bicycle helmets
• Protective work shoes and gloves

• Category 3 – strong protection

This category includes all PPE that protects against irreversible or fatal damage. For example, this could be nuclear radiation, intense heat or cold, falls, severe cuts, electric shock, and hazardous materials.

Examples:

• Life jackets
• cut resistant gloves
• Laboratory suits
• Respirators

Depending on the protection category, you must meet strict requirements to comply with the PPE regulation when produced in China. We will be happy to inform and advise you, and also carry out the necessary tests in our laboratories.

PSA testing in China

BEIDE Compliance Laboratory is a subsidiary of the Frisch Agency that performs specific demanding tests. Among them are the PPE tests in China, which are necessary to ensure compliance with the PPE regulation for production in China.

We evaluate for you which category your PPE product belongs to and subject it to the necessary PPE testing in China. This offers you a variety of advantages. This way, when BOTH Compliance Laboratories perform an inspection, you do not lose time and there can be no misunderstandings. We take care of the entire process for you.

Declaration of conformity according to PPE regulation

As part of our services, we not only carry out the PPE testing in China for you, but also, for example, prepare the technical documentation with verification of the safety and health requirements, realize the internal production control and handle the entire conformity procedure for you.

Products of PPE category 2 and higher must be tested by a notified body. In this case, we prepare everything for it and accompany the processes until completion.

It is not possible to import PPE items without complying with the PPE Regulation. We will take care of it for you.