It has fully assessed 11 with only one assessed as being PBT or vPvB
. With most of the rest it had stated it needs more information or test data.
"The main problem is going to be with the drawing up of registration dossiers on the CMR, PBT and vPvB
substances because of the amount of safety data required," said one consultant.
The seven substances are: musk xylene (vPvB
); 4,4`-diaminodiphenylmethane (MDA - carcinogenic); short-chained chlorinated paraffins (PBT and vPvB
); hexabromocyclododecane - (HBCDD - PBT); bis(2-ethylhexyl)phthalate (DEHP - toxic for reproduction); benzylbutylphthalate (BBP - toxic for reproduction); and dibutylphthalate (DBP - toxic for reproduction).
But they are the ones requiring the most work in terms of gathering of safety data because the higher the volume the more test data is required by the legislation, while even more information is demanded for the safety profiles of CMRs, PBTs and vPvBs
In REACH the most hazardous substances ("substances of very high concern") are identified as those that are classified as carcinogenic, toxic to reproduction or mutagenic in category 1 or 2, PBT or vPvB
, or endocrine disrupting or give rise to an "equivalent level of concern" (REACH article 57).
This is as long as they are not classified as CMRs or have other hazards of high concern, such as being persistent, bioaccumulative and toxic (PBT) or vPvB
, in which case the data their producers or importers will have to provide will be as onerous as that for higher tonnages.
Certain substances, such as PBT and vPvB
, may be authorised only if the socio-economic benefits outweigh the risks and if there are no suitable alternatives.
"But there are doubts about whether they are also bioaccumulative so that they could be categorized as vPvBs
Substances in the one to ten metric ton range, which account for two-thirds of the chemicals covered by REACH and the majority of those used in coatings formulations, will be subject to the least stringent registration rules, as long as they are not classified as CMR, PBT or vPvB
This is an implementation of the European Commission's interim strategy for management of persistent bioaccumulative and toxic substances (PBTs) and very persistent, very bioaccumulative substances (vPvB
) (CEC 200lb), and the criteria used are shown in Table 1.
The absolute need to provide more clarification of the possible exclusions related to 'adequate control' for certain PBT (persistent, bio-accumulative and toxic) and vPvB
(very persistent and very bio-accumulative) substances and products with a negative impact on reproduction.
The second is that for highly worrying products such as CMR (carcinogenic, mutagenic or toxic to reproduction), PBT (persistence, bioaccumulation) and vPvB
(very persistent and very bioaccumulable) products, for which it is not possible to determine safe levels by current methods, these methods are to be examined within 12 months of the Regulation coming into force.