P
14 Posts in this encyclopedia categoryPackaging Act
The German Packaging Act (Verpackungsgesetz, VerpackG) requires manufacturers and importers to register with a dual system and pay a licensing fee for packaging placed with end consumers in Germany. Glove manufacturers and importers selling to Germany are subject to the VerpackG.
Penetration
In the context of protective gloves, penetration is the movement of a chemical through visible material defects such as holes, tears, or inadequate seams. The penetration test per EN ISO 374-2 checks the leak-tightness of the glove against water and air. Penetration is distinct from permeation.
Permeation
Permeation is the diffusion of a chemical at molecular level through intact glove material without visible damage. It occurs invisibly and cannot be detected by visual inspection. Breakthrough time and permeation rate are measured per EN 16523-1. A passed penetration test or low AQL does not exclude permeation.
Personal Protective Equipment (PPE)
Personal Protective Equipment (PPE) - known in German as PSA (Persoenliche Schutzausruestung) - is the legal umbrella term for all products worn or held by a person to protect them against risks to health and safety. EU requirements are governed by PPE Regulation (EU) 2016/425. PPE is classified into three risk categories (I, II, III) and must carry CE marking.
Phthalates/Plasticisers
Phthalates are organic compounds used as plasticisers in PVC (vinyl) to reduce hardness and brittleness. Phthalates such as DEHP (di-2-ethylhexyl phthalate) are classified as reprotoxic (SVHC) and restricted in the EU for certain articles under REACH Annex XVII.
Placing on the Market
Placing on the market is the EU legal term for the first supply of a product on the EU internal market, whether for payment or free of charge. At the time of placing on the market, the product must comply with all applicable EU requirements. The term is legally defined in MDR (EU) 2017/745 and PPE Regulation (EU) 2016/425.
Plasticisers
Plasticisers, or rather softeners, are substances that are added to brittle resins (thermosets) and plastics (thermoplastics) to make them more pliable and elastic in use or further processing.
PPE Regulation (EU) 2016/425
PPE Regulation (EU) 2016/425 is the binding EU framework for personal protective equipment. It replaced Directive 89/686/EEC in 2019 and classifies PPE into three risk categories (I, II, III). The Regulation governs requirements, conformity assessment, CE marking, and market surveillance.
Product Safety Act (PrSG)
The German Product Safety Act (Produktsicherheitsgesetz, PrSG) was the national law implementing the EU Product Safety Directive. Since December 2024, the new EU General Product Safety Regulation (EU) 2023/988 (GPSR) applies directly across all EU Member States, replacing both the PrSG and the old Directive 2001/95/EC.
Produktsicherheitsverordnung
The General Product Safety Regulation (EU) 2023/988, known internationally as the GPSR, has governed the general safety of consumer products in the EU since 13 December 2024. It replaces the General Product Safety Directive 2001/95/EC and applies directly in all Member States. For medical devices and PPE, the sector-specific frameworks MDR and the PPE Regulation take precedence; the GPSR applies in addition.
PSA Cat II
PPE Category II protects against risks beyond Category I but not reaching the severity of Category III. Typical examples: mechanical protective gloves per EN 388, safety footwear, general industrial helmets. An EU type-examination by a Notified Body is mandatory.
PSA Cat III
PPE Cat III (Category III) is the highest risk level for personal protective equipment under PPE Regulation (EU) 2016/425. It covers PPE protecting against serious risks that could result in permanent health damage or death. A Notified Body and ongoing production surveillance are mandatory.