• If chemical substances in anhydrous form are included in the IECSC or have been registered , their hydrates shall be managed in the same way and vice versa
The Guidance Documents also adjusted the type of notification . They laid down that :
• Substances in the tonnage band ≤1 tonne / year , polymers whose monomers or reactants contain < 2 % w / w new substances , and polymers of low concern , are subjected to recording ( except for polymers within the exclusion scopes of polymer record )
• Substances in the tonnage band between 1-10 tonnes / year are subjected to simplified registration
• Substances in the tonnage band > 10 tonnes / year are subjected to regular registration
In terms of data requirements , under Order No , 12 , registrants of regular and simplified registration must submit ‘ minimum data ’, which includes basic data and special data . For regular registration , if the minimum data is not sufficient to evaluate the environmental risks of the substance , other data will also be required ( Figure 2 ). The minimum data for simplified registration include physical and chemical data , and persistence , bioaccumulation and acute toxicity to aquatic environment data . If the substances are considered both persistent and bioaccumulative , special data for chronic toxicity to the aquatic environment are also required . For regular registration , these include physical and chemical data , toxicology and eco-toxicology data . If the substances are considered either persistent or bioaccumulative , then special data for toxicology and ecotoxicology are also required . The term ‘ highly hazardous substances ’ refers to chemical substances that are persistent , bioaccumulative and toxic ( PBT ), very persistent and bioaccumulative ( vPvB ) or high-risk substances with equivalent hazards . According to the judgement criteria provided by the guidance documents , applicants can determine whether their products are PBT based on the basic data . If basic data cannot determine that the substance is not PBT , it will be deemed PBT unless further data is provided . Applicants for regular registration or new usage registration for highly hazardous substances must submit a socio-economic benefits analysis materials . These must demonstrate the necessity of the particular use and show that the substance has competitive advantages over the existing substances in terms of its human health and environmental impacts , and socialeconomic benefits . Under the Guidance Documents , enterprises can apply for confidential business information ( CBI ) protection for regular registration , simplified registration and recording of materials . They must submit relevant documents demonstrating the necessity for CBI protection and list the specific information to be protected – though this is not required for recording . The documents also make provisions for the limitation period for CBI protection . For identification information , such as chemical ‣
Application data
Minimum data requirements
Other data ( exclusively applicable to regular registration )
Physical & chemical data
Toxicology & eco-toxicology data
Basic data
Special data ( exclusively applicable to persistent & bioaccumulative substances )
Figure 2 – Data requirements under MEP Order No . 12
46 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981