石油与染料化学家协会对REACH的评议

 

 

 

 

 

 

 

 

I am Chairman of the Midlands section of O.C.C.A. ( Oil and colour Chemists Association ) and would like to comment on behalf of myself and other members within the Midlands section. O.C.C.A. is an organisation consisting of qualified industrial chemists and other professional people, with a membership in many different countries on a global basis. We all wholeheartedly agree that health & safety and the environment are of extreme importance to us personally and with respect to the world in general. We probably have more of a vested interest than a lot of people who will comment on these draft proposals because we have to work with many of the chemicals involved on a daily basis. The main point that worries us is that we feel that this blanket set of proposals is trying to achieve too much, too fast, too soon. Common sense has to prevail and we need to propose a more balanced draft, which is based on sound chemical knowledge and practicalities allied with the obvious financial considerations.

One aspect that is missing from the draft is the positive effect of chemicals on the environment and the benefits that they can provide. A simple example from our industry and experience is paint to prevent metallic surfaces from rusting.

Because of the financial implications of introducing new chemicals etc. that is proposed, valuable research and development which could enhance industry throughout Europe may be lost, or even taken out of Europe completely to much less regulated areas of the world.

The proposals also need to consider the effect on employment throughout Europe within the Chemical Industry, as the draft, as it stands would certainly lead to job losses on a major scale and re-location to other parts of the world, with little or no improvement to health, safety or the environment.

 

 

 

 

2.    Chemical safety assessment

 

o        The Downstream User Chemical Safety Assessment should be carried out for the preparation, but not as an accumulation of Chemical Safety Reports delivered by raw material suppliers.

o        Cut off limits, as set down in the Dangerous Preparation Directive, are essential in avoiding tracking down single substances through the entire supply chain.

o        The information that non dangerous substances are part of a preparation is not per se helpful with regard to safety assessments.  For workability, exposure assessment for substances in preparations should be restricted to only those preparations classified as dangerous.

o        Downstream User Chemical Safety Assessments are useless unless complete data are provided by the raw material suppliers. To carry out these assessments one year after the coming into force of the regulation will be difficult. As much of the information required to assist with the Chemical Safety Assessment will not be available until 11 years after entry into force of this Regulation we consider that Downstream User Chemical Safety Assessments must only be delivered 12 years after entry into force of this Regulation.

o        The paint and printing ink industries require to be treated on an equal basis as far as submission of information to the European Agency is concerned. Since 1 tonne per year is the threshold used for producers and importers of substances, the downstream user should be treated accordingly and not be obliged to submit any information below that threshold. The proposed limit of 250 kg per year is absolutely unacceptable.

o        In preparing the Downstream User Chemical Safety Assessment the downstream user has to assure that the exposure scenarios given by the raw material supplier apply for his own site and for those of his customers and their customers down the supply chain.  This requirement should be limited for the downstream user to the activity undertaken on its site.

 

 

 

o        The whole REACH system is too bureaucratic. To inform the customer six different documents are necessary. Instead of this huge amount of paper only the SDS should be used to inform the clients. They are accustomed to the SDS.

o        It is disproportionate and impractical that everyone has to keep all information that anyone has provided under REACH.  A time requirement of e.g. 3 years should be specified to keep information limited to own company data.

o        The duty to communicate substance registration numbers to the immediate downstream users is unacceptable for confidentiality reasons.

o        Chemical Safety Reports for all components present in each of the formulations are absolutely unsuited for the task of information transfer. With 11 (and in near future 18) official languages in the EU any documentation must be translated to each language, a task that cannot be conducted. Furthermore, most users do not wish to receive excessive amounts of paper, but short reliable instructions on how to operate a product safely. SDS as currently provided insure the right amount of information. R and S phrases can be standardised and easily translated and used by all members of a certain industry. This enables everybody to perform correct risk management.

o        There is no need to make information available to Member States: the Agency should be solely responsible for requesting and co-ordinating information required under REACH.

 

 

o        For consistency and workability the registration procedure should only involve the Agency.  The role and involvement of the Member States is unnecessary, adds to the bureaucracy of the process and risks compromising the workability.

o        A minimum concentration limit for a substance in a preparation must be specified for it to be an intended use to avoid chasing every molecule and rendering the system unworkable.  We propose that only substances intentionally present in preparations above the concentration limits specified in the Dangerous Preparation Directive need to be considered.

o        Pre-registration is important to downstream users so that they can identify within a reasonable period which substances will not be supported for their particular use/exposure scenarios.  As it is the low volume substances that are at most risk of not being supported we propose the following deadlines for phase-in substances:

(a) manufactured or imported at 1000 t/a or greater: 4.5 years after enforcement of the Regulation;

(b) manufactured or imported at 1 t/a or greater: 7.5 years after enforcement of the Regulation.

o        Pre-registration information provided must contain information on intended uses.

o        Down stream users should also be able to participate in Substance Information Exchange Fora.

 

 

 

     

            

 

o        Downstream users should be given the opportunity to participate in consortia if they so wish.

 

 

o        The disclosure of the registration number of substances in preparations means that confidentiality is no longer possible.  Producers lose their specific know how advantage. With regard to competitors from outside the EU the European industry will suffer from reduced export opportunities. However, imports into the EU will certainly be possible due to the rules of WTO. This might lead to a situation, where articles containing substances about which no information is available will replace articles made in Europe.

 

 

 

(a) the decision-making procedures are complex,  bureaucratic and have unrealistic time-frames

(b) much of the basis on which the various tasks are to be carried out are unclear,  imprecise or open-ended

(c) the Evaluation of a  substance is never finalised.

(a) to make industry, not Member States, responsible for chemical safety

(b) to eliminate the bureaucratic and inefficient current decision-making processes.

(a) to reflect the responsibilities placed on industry for chemical safety

(b) to ensure there is a legal certainty to the Evaluation process, and

(c) to make Evaluation an efficient, effective and non-political process.

     

not be required to notify the Agency for first use of an authorized

substance; this will be covered with the principal application for

authorisation.

 

 

 

o        Scope

The scope of REACH is too ambitious and will not be effective.

 

o        Reduction of number of available raw materials

First evaluations show that between 20 and 40 % of raw materials will vanish from the market.  The proposals will require significant resources and costs for product support and product reformulation. In addition this will lead to a competitive disadvantage with the full burden of socio-economical consequences in Europe.

   

o        Consistency

Many of the requirements are imprecise and unclear, i.e. the definition of ‘use’ that should be consistent throughout the legislation.

 

o        SME