The publication of the new glove standard, EN ISO 21420 which replaces EN 420 builds on this and responds to the growing trend in standardization to address the topic of “innocuousness”. It also takes into consideration the requirements of the EU PPE Regulation as ISO 21420 will help address the Essential Health and Safety aspects of Annex II, where PPE must be made so that its free of inherent risks and nuisance factors and must not be made from materials that can adversely affect the health and safety of users. The new EN ISO 21420 will provide further alignment with the Registration, Evaluation, Authorisation and Restriction of Chemicals, legislation on hazardous substances or substances of very high concern.
· Introduction of a new pictogram for electrostatic properties EN 16350
· Removal of the protein content test in natural rubber gloves
· Removal of minimal glove length requirements, unless required by a specific standard i.e. welding gloves
· Introduction of date of manufacture markings
· Other subtle changes concerning information for users, additional information on donning/doffing, product integrity checks before use.
· chromium VI (Test method EN 17075) : applicable to all leathers; less than 3mg/kg
· nickel release (Test method EN 1811) : applicable to metallic components in prolonged contact with skin; less than 0.5µg/cm2/week
· pH value (Test method ISO 4045 leather or ISO 3071 textile) : applicable to all materials; requirement: pH value shall be between 3.5 – 9.5
· azo colourants (Test method ISO 17234-1 leather or ISO 14362-1 textile) : applicable to all dyed leathers and textiles; requirement: less than 30mg/kg for each of the carcinogenic aromatic amines listed in the analysis methods
· dimethylformamide (DMFa) (Test method prEN 16778) : applicable to all materials containing polyurethane (PU); less than 1,000mg/kg ( 0.1% weight/weight)
· polycyclic aromatic hydrocarbons (PAHs) : applicable to rubbers and plastics in direct contact with the skin; less than 1mg/kg of each of the eight restricted PAHs
· The levels of performance should be based on the lowest results obtained before and after cleaning cycles (consideration of care instructions for testing).
· For gloves worn in ATEX environments, the electrostatic properties shall be tested (Test method EN 16350).
Important changes covering glove marking
· Manufacturer’s name and postal address
· Glove designation
· Size designation
· Relevant pictograms and corresponding level(s) of protection
· Date of manufacturing (month and year)
· The CE marking
* If marking on glove is not possible, due to the characteristics of the product then the marking shall be affixed to the first packaging enclosure.
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.
EU No 10/2011 is applicable regulation for all the Food contact material or Article made up of Plastics.
The (EU) No. 10/2011 d introduces separate rules for testing conditions for OML and SML testing.
The analytical and technical description of migration tests are established in the following EN standards:
• Several parts of the EN1186 standards describe the testing procedure for overall migration testing.
• Several parts of the EN13130 standards describe the general testing procedure for specific migration testing including the analytical measurement of about 26 substances.
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