As of 21 April 2018, Directive 89/686/EEC will be repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment. The new PPE Regulation is aligned to the New Legislative Framework policy. In addition, it slightly modifies the scope and the risk categorisation of products. It also clarifies the documentary obligations of economic operators.

Main changes

– Change of categorisation from product related to risk related
– Change of classification for certain product categories;Hearing Protection, now categorized as ‘harmful noise’ (risk) is moving from category II to III
– EC Declaration of Conformity to be provided (or with a web link) with each product- 5 year validity / expiry date for new EU Certificates
– Increased obligations on ‘economic operators’ – being the total supply chain, including manufacturers, importers and distributors.

This standard defines the general requirements for ergonomy, product design, construction, comfort, efficiency and marking.
– The gloves themselves should not impose a risk or cause injury.
– The pH of the gloves should be as close as possible to neutral.
– The pH value of leather gloves must be between 3.5 and 9.5 and the chrome content must be less than 3 mg/kg.
– The manufacturer must specify whether the glove contains substances that can cause allergies.
– Sized by reference to an agreed common European hand size. See the table below.

The Framework Regulation (EC) 1935/2004 states that food contact materials shall be safe. They shall not transfer their components into the food in quantities that could endanger human health, change the composition of the food in an unacceptable way or deteriorate the taste and odour of foodstuffs.

The American National Standards Institute (ANSI) has released a new edition of the ANSI/ISEA 105 standard – 2016. The changes include new classification levels, which includes a new scale to determine the ANSI cut score and a revised method for testing gloves to the standard.
The new ANSI standard features nine cut levels that reduces the gaps between each level and better defines protection levels for the cut resistant gloves and sleeves with the highest gram scores.

Dimethylformamide is an organic compound used as an industrial solvent and in the production of fibres, films and surface coatings. This colourless liquid is miscible with water and the majority of organic liquids. Dimethylformamide is odourless whereas technical grade or degraded sample residues in finished products often have a fishy smell.
DMF is registered under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals : regulation of the European Union) as mono-constituent substance (10,000-100,000 tonnes). The registration dossier therefore has to comply with the information requirement in REACH Annex VI-X, i.e. the highest level in REACH regarding information covering physical-chemical, toxicological and eco-toxicological properties. In December 2012, DMF was included on the candidate list of Substances of very High Concern (SVHC) due to its CMR2 properties and is now further recommended to be included on Annex XIV as a substance subject to authorisation, DMF is not on the Community Rolling Action Plan (CoRAP) for substance prioritized for evaluation. There is no EU risk assessment for DMF (CAS No. 68-12-2).

The OEKO-TEX® Standard 100 is an independent testing and certification system for textile raw materials, intermediate and end products at all stages of production. Examples for items eligible for certification: Raw and dyed/finished yarns, raw and dyed/finished fabrics and knits, ready-made articles (all types of clothing, domestic and household textiles, bed linen, terry cloth items, textile toys and more).
OEKO-TEX® testing for harmful substances always focus on the actual use of the textile. The more intensive the skin contact of a product, the stricter the human ecological requirements to be met.

Testing for harmful substances includes:
– illegal substances
– legally regulated substances
– known harmful (but not legally regulated) chemicals
– as well as parameters for health care