Carcinogen restrictions directive

Restrictions on Marketing and Use Directive. Sets detailed restrictions and total bans on a number of individual substances, e.g. the use of TBT in paint, the use of cadmium, the use of carcinogenic substances as well as approximately 30 other substance specific measures (EU, 1976). 

Dyes such as benzidine-based dyes which are classified as carcinogens, mutagens, or teratogens according to the Directive 67/548/EEC (CMR substances, Table 8.3), are subject of the Council Directive 76/769/EEC (Restrictions on the Marketing and Use of Certain Dangerous Substances and Preparations) and must not be marketed as such or in preparations if they contain more than the maximum concentration of 0.1%. In principle, the directive does not ban the import of articles , e.g., textiles dyed with benzidine-based dyes, because articles are not covered by the directive. 

Automatic bans for carcinogenic, mutagenic or reprotoxic (CMR) substances following the restrictions procedure under Directive 76/769 have been excluded (step 2) because these will continue to apply under REACH. The result of the risk criteria evaluation for each substance according to the decision-making matrix is shown in Table 6.1 (step 3). Based on the selection procedure detailed in Section 5.3.2, the most suitable regulatory outcome... 

The facility must be designed to control access. Signs should designate restricted areas. Clothing requirements for entry should be identified. There should be directional air control with adequate ventilation rates. Primary containment equipment such as chemical fume hoods, a Class I or Class II (Type B) biological safety cabinet, or a glove box system should be available for use with known or suspect chemical carcinogens or other toxic substances. 

To protect human health and improve consumer safety, the European Parliament and the Council of the European Union (EU) pubhshed Directives 2002/61/EC and 2003/3/EC on September 11, 2002 and January 6, 2003, respectively. These restrict the use of carcinogenic azo-dyes in textiles and leather articles and prohibits the sale of such articles dyed with the restricted azo dyes. Directives 2002/61/EC and 2003/3/EC had been transposed into national laws and put into effect in the member states respectively by September 11,2003 and June 30,2004. Aromatic amines (azo dyes) (22 kinds) specified and prohibited by Directive 2002/ 61/EC are listed in Table 3.3. 

For example, the Limitations Directive prohibited the use of chloro-l-eth-ylene for one application, as an aerosol propellant. In some cases, notably with respect to PCBs, the Limitations Directive imposed an outright ban. Restrictions were based on the potential to pose a risk to human health, particularly from carcinogenicity or in some cases a potential risk to the environment. Under the initial Directive and multiple amendments, authorities restricted 42 substances or groups of substances, which included a total of approximately 900 compounds. ... 

Across the ocean, the use of HCB as a peshcide was banned under Council Directive 79/117/EEC of 21 December 1978, which prohibifed fhe markehng and use of HCB in the European Union after 1981 but allowed its production for purposes of research or analysis or for exporf [113]. More generally, in 1997 HCB became regulafed under fhe Limifahons Direchve which identified it as a carcinogen [114]. In 2004, Regulahon (EC) No 850/2004 [115] solidified the European Union s commitment to the Stockholm Convention and its restrictions on HCB. HCB cannot now be placed on the market as a substance or mixture intended for consumer use (REACH Armex XVII, Entry 28 - Appendix 2 [116]). 

Studies with micro ZrOj showed that these particles have low carcinogenic potential under severe overload conditions, and the few research works relative to nano ZrOj (without or with surface modification) did not find any pulmonary adverse effects (Landsiedel et al., 2014 Klein et al., 2012). Further, the final PM with nano ZrOj is unlikely to present a direct risk because the NM are trapped in the solid resin. Though, the NM might still be released to the environment at the end of the product s service life (Figure 2), and this risk could not be disregarded (Roes et al., 2012). However, the present analysis is only addressed and restricted to the risk assessment during the PM production. 

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