Chromium VI and Azo-Dye Content of Leather Products Available to UK Consumers

Transcription

1 Chromium VI and Azo-Dye Content of Leather Products Available to UK Consumers A joint initiative between Trading Standards, the Health and Safety Executive and the British Safety Industry Federation Executive Summary Report

2 Contents Introduction... 3 Review of Intelligence as of Method... 5 Results... 5 Conclusions... 8 Recommendations... 9 Appendix 1 Example Costs Bibliography... 14

3 Introduction Various consumer goods are made from leather: bracelets, fashion gloves, baby shoes and protective gloves. This process involves the use of processing agents which may produce Chromium VI and Azo Dyes. The Chromium VI and Azo-Dyes (which cleave to aromatic amines) content of leather products are a concern due to the safety risks they present, and are therefore restricted by Annex XVII of Regulation (EC) No 1907/2006. The data below is reproduced from the RAPEX database. Chromium VI Product Category Number of Notifications Number Generated by UK Leather Fashion Gloves 30 0 Baby Shoes/ Children's Footwear 58 0 Protective Gloves 43 0 Straps and Bracelets 4 0 TOTAL Table 1: RAPEX Data Extracted from 437 Notifications for Chromium VI covering 11 Product Categories Azo-Dye Product Category Number of Notifications Number Generated by UK Leather Fashion Gloves 6 2 Baby Shoes/ Children's Footwear 4 0 Protective Gloves 11 0 Straps and Bracelets 6 0 TOTAL 27 2 Table 2: RAPEX Data Extracted from 305 Notifications for Azo-Dyes covering 11 Product Categories In 2015, the British Safety Industry Federation (BSIF) sampled leather rigger gloves for Chromium VI and Azo-Dye content. All of the products originated in India, Pakistan and China. The suppliers of the samples were all established businesses in the UK with a recognised international quality system.

4 Sample Number Azo-Dye or Chromium VI Concentration (ppm) Limit (ppm) Pass/Fail 1 Azo-Dye Fail 2 Chromium VI Fail 3 Azo-Dye Fail 4 Chromium VI 18 3 Fail 5 Azo-Dye Fail 6 Chromium VI Azo-Dye Fail Fail 7 Chromium VI Fail 8 Azo-Dye Fail Table 3: Sampling Data Produced by British Safety Industry Federation, Review of Intelligence as of 2016 Based on the RAPEX and BSIF information, it is expected that leather baby shoes, fashion gloves, protective gloves and bracelets/straps on sale to consumers in the UK will contain excessive levels of Chromium VI and Azo-Dyes. The BSIF study suggests that some protective gloves sold to the trade are also likely to be unsafe. Whilst the EU has laws prohibiting Chromium VI and Azo-Dyes in leather articles above specified levels, this does not necessarily protect consumers who purchase products directly from 3rd Countries. It is important to establish whether or not consumers are protected to the same degree when purchasing products from 3rd Countries compared to purchasing products from the EU. The information currently available is not specific enough to address this point.

5 Product Type Method 157 samples consisting of leather bracelets, fashion gloves, baby shoes and protective gloves were analysed. Samples were obtained from the EU and from 3 rd Countries via the internet. Protective gloves included those sold to the public and those sold directly to the trade. The samples were tested using methods described in national standards EN ISO :2016 Determination of certain aromatic amines derived from azo colourants followed by GC-MS Analysis, and Chromium VI was assessed using BS EN ISO :2007 by UV-VIS Spectrophotometer. Results Total Number of Samples Number of Samples within REACH Restriction Limits Number of Samples Over CrVi Limit ( 3ppm) Number of Samples Over Azo Dyes Limit ( 30ppm) Table 4: Total number of samples complying and in breach of REACH restrictions Number of Products Within and Exceeding REACH Restriction Limits Trade PPE Gloves PPE Gloves Baby Shoes Number of Products Within Limits CrVi ( 3ppm) Azo Dyes ( 30ppm) Figure 1: Compliance with REACH restriction limits

6 Specific Sample Cr Vi Concentration Range (ppm) Chromium Vi Concentration Range by Sample Type Trade PPE Gloves Fashion Gloves PPE Gloves Baby Shoes Maximum Permitted Concentration Number of Samples within Range Figure 2: Number of samples falling within ranges of Chromium VI detected across the samples. Maximum permitted concentration shown at 3ppm. 4-Aminobiphenyl (ppm) Benzidine (ppm) Baby Shoes 185 3,3 -Dimethoxybenzidine (ppm) Bracelet/Strap Fashion Gloves 148 Trade PPE Gloves 55 Trade PPE Gloves Fashion Gloves Table 5: Concentrations of amines found in samples which breached the REACH restriction for Azo Dyes Sample Type Country of Sale Product Claims Restricted Substance Detected PPE Gloves EU EN388 compliant Chromium VI PPE Gloves EU EN388 EN420 Chromium VI Trade PPE Gloves EU EN388 & EN407. CE Mark. Benzidine Trade PPE Gloves EU CE marked on label. Chromium VI Baby Shoes 3rd Country EN71-3 compliant, Intertek tested Chromium VI Trade PPE Gloves EU CE marked (typea), EN388 (mech 4,1,2,2), EN407Therm (4,1,3,X,X) 4-Aminobiphenyl, Benzidine, 3,3 - Dimethoxybenzidine Table 6: Further details of samples which breached REACH restrictions and were sold with claims relating to compliance with the law

7 Sample Reference Dudley/3 Dudley/1 Suffolk Imports/1 Suffolk Imports/2 Staffordshire/3 Follow-up Action Internal Inspection by business. Request for technical documents by authority. Internal Inspection by business. Request for technical documents by authority. Internal Inspection by business. Request for technical documents by authority. Home authority referral Suspension notice. RAPEX notice. ICSMS record. Details The business quarantined and inspected stock of 8,127 pairs of gloves. Work is ongoing together with the Primary Authority. Technical documents for the product were compliant. Business has issued a warning notice in all stores at the till point. Work is ongoing together with the Home Authority. The business inspected their stock and sent a sample to Intertek. That sample passed testing. Home authority referral After the suspension notice was issued, the business voluntarily destroyed the seven remaining items in stock. The batch was produced in The authority decided against requiring a product recall. Hereford/3 & 6 Contacted ebay The products were supplied from a 3 rd country via ebay. A request was sent to ebay to remove the listings Southend/2 & 4 Refer to Primary Authority HSE/8 & 21 & 26 & 33 & 34 Suffolk/3 & 8 & 10 & 11 Co-operation with supplier Contacted ebay The primary authority confirmed that the product listings had been taken down from Amazon and Ebay, and the sellers informed of the reasons. Voluntarily removed from market - ongoing discussions with supplier and supply chain to establish QA procedures The products were supplied from a 3 rd country via ebay. A request was sent to ebay to remove the listings Table 7: Descriptions of action taken by authorities or businesses

8 Conclusions Due to statistical analysis, the following conclusions were reached: 1) there is no significant different of compliance in the products purchased from the EU compared to products from 3 rd Countries and 2) there is no significant difference of compliance in the leather PPE gloves intended for consumers and those intended for trade use. Failure rate (Number, %) Chemical test type Group 1 Group2 Statistical significance test CrVI testing 3 rd Country, 7(17%) EU, 12(11%) p-value=0.310 >0.05 Not statistically significant Azo Dye testing 3 rd Country, 3(7%) EU, 3(3%) p-value=0.349 >0.05 Not statistically significant CrVI testing PPE Gloves, 6(16%) Trade PPE Gloves, 3(9%) Azo Dye testing PPE Gloves, 0 Trade PPE Gloves, 2(6%) p-value=0.485 >0.05 Not statistically significant p-value=0.220 >0.05 Not statistically significant Table 8: Summary Findings of Statistical Analysis The results reflect the pattern in the RAPEX information. Most failures are Chromium VI, and within that most Chromium VI failures are with baby shoes and PPE gloves, followed by fashion gloves and then bracelets. It is possible to produce leather which will not form Chromium VI and can therefore be avoided (Deivkavathi, Suresh, Rose, & Muralidharan, 2014). Detecting Chromium VI in 32% of the samples suggests a general issue with the tanning methods and controls in place at those manufacturers. Protective gloves can contain Chromium VI and Azo Dyes, even though they are CE marked and sometimes claim compliance with EN 388. The PPE gloves sampled during this project were category II PPE. Category II PPE does not require ongoing quality assurance by a 3 rd party, and this could contribute to the supply of leather PPE gloves which contain Chromium VI and/or Azo Dyes. This reflects the findings in the BSIF sampling exercise.

9 Recommendations 1. The sampling method did not take in to account the time lapse in obtaining the sample and carrying out analysis. Chromium VI formation can take place at any time. Sampling methods should control and reduce the time between obtaining and analysing the sample. 2. Future sampling projects should identify the quantity of samples, and statistically sound methods, needed to draw proper conclusions. This type of conclusion requires statistical analysis, therefore advice should be obtained advice from experts e.g. statisticians. 3. Only a basic statistical analysis was possible. This was due to the number of unknown variables in the sampling method. In designing projects, advice should be obtained from the statistician experts to ensure that the method is sufficiently robust to allow proper statistical analysis. 4. During the course of this project, an authority carried out a sampling exercise to examine leather belts, wallets/purses, hand bags and phone cases. This exercise consisted of eight samples and all of them passed analysis for Chromium VI and Azo-Dyes. All of the products were purchased from highstreet suppliers in the UK. The RAPEX data does support targeted sampling of these products, and reveals a lack of information from the UK. It is recommended that further sampling takes place with these product categories on a wider scale. 5. Future projects should investigate where the leather was dyed and not just where the final product originated, as well as the age of the product. This will help build a picture of where the breaches originate. This could be as part of a wider investigation of the leather supply chain. 6. BEIS and the relevant ADCO groups should consider the following issues: a) Responsibility for the formation of Chromium VI Because the background document to the opinion on the Annex XV dossier proposing restrictions on chromium VI leather articles used by the Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC)1 states that chromium VI compounds can be formed during: a) the tanning/re-tanning of leather; b) the formation of articles made from tanned leather; and c) in finished articles.

10 It may not be possible to establish at which point in the supply chain the breach first occurred, if indeed it did (i.e. is it the tanner of the leather who triggers the offence; the producer of the article; the importer/supplier or the article; the retailer, or did the breach occur between sample collection and analysis?). The REACH Regulation doesn t include any due diligence defence. However, factors may exist to mitigate why the breach has occurred. (e.g. testing may have been undertaken to check compliance, and the chromium VI may have formed posttesting). Whilst this doesn t remove the breach, issues may exist which may need to be taken into consideration. b) Timescale for exposure with respect to chromium VI compounds The issue of timescales for exposure was considered during the drafting of the Chromium VI compounds in leather restriction. The decision of the Committee for Risk Assessment was, that, based on the scientific evidence available, the risks were such that it was appropriate to state that the restriction should apply to leather articles or leather parts of articles coming into contact with the skin. The wording prolonged was NOT included. c) Definitions for exposure with respect to the azo dyes restriction The azo dyes restriction uses the phrase may come into direct and prolonged contact. No definition of prolonged is provided with regard to the restriction, nor has one subsequently been prepared. Work has been done at an EU level to produce a definition for nickel, as that substance also contained the wording direct and prolonged contact with skin in its restriction. For Nickel, a Q&A7 (number 0935 on the ECHA website) has been produced which states that: Prolonged contact with the skin is defined as contact with the skin to articles containing nickel of potentially more than: >10 minutes on three or more occasion within two weeks, or >30 minutes on one of more occasions with two weeks. The skin contact time of 10 minutes applies when there are three or more occasions of skin contacts within a two week period. The skin contact time of 30 minutes applies when there is at least one occasion within a two-week time period". Whilst this definition has not been prepared for the azo dyes, it may serve as an example of how the word prolonged could be interpreted. However, attention is drawn to the fact that the clarification took account of recent scientific data on nickel allergy and a similar consideration has not been conducted for azo dyes/colourants. Therefore direct read-across of the definition is not appropriate.

11 d) Test methods The REACH legal text states that the test methods referred to in Appendix 10, Annex XVII of REACH must be used to assess compliance of an article with respect to restriction 43 (azo dyes and colourants). The wording of the chromium VI compounds restriction2 does not reference a specific method. However, at the point the restriction came into force, the Regulation stated that EN ISO was the only internationally recognised analytical method currently available to detect chromium VI in leather, including leather in articles. e) Issues with test methods Testing and analysis of azo dyes should follow the method prescribed in Appendix 10, to Annex XVII of the REACH legal text. This refers to the EN ISO :2010 test method, even though the method itself has been replaced by a 2015 version. 7. The same groups could also consider developing a standardised sampling method for analysis of Chromium VI in leather products, to mitigate the issue with Chromium VI forming after the sample is obtained. 8. The wording used for REACH restrictions is different and some are more difficult to assess than others. For example, the restrictions in this project use phrases such as prolonged skin contact which does not have a definitive meaning. The wording of the REACH restriction should be considered at the project initiation stage, to resolve any ambiguities. The testing methodology should also be researched as there may be inconsistencies in the method referenced in REACH and the current state of scientific knowledge.

12 Appendix 1 Example Costs

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14 Bibliography Assem, L. Z. (2007). Chromium Toxicology Overview. Retrieved April 25, 2016, from hromium_toxicological_overview.pdf. Last accessed 25/04/2016 CSTEE. (1999). Assessment of the Report by LGC "The risk of cancer caused by textiles and leather goods coloured with Azo-Dyes". Retrieved March 3, 2017, from out27_en.htm. Last accessed 28/04/2016. Deivkavathi, G., Suresh, S., Rose, C., & Muralidharan, C. (2014, January Vol 21). Prevention of carcinogenic Cr (VI) formation in leather - A three pronged approach for leather products. Indian Journal of Chemical Technology, pp EU Commission. (2014, March 25). Commission Regulation (EU) No 301/2014. Retrieved March 03, 2017, from EU Commission. (2016, June). Trade Report Comparisson per Year. Retrieved March 9, 2017, from %20ITI%20TEX%20- %20Trade%20YTD%20Report%20NC%20Product%201st%20Level%20Groups%20- %2006%20June%20-%20Leather.pdf Marks and Spencer. (2014, March). Chromium VI Management A Practical Guide. Retrieved March 03, 2017, from