CEFIC proposal for the scope of REACH regarding Intermediates – revised version
August 19, 2002
Objectives of the White Paper
The overriding goal of the White paper is sustainable development. In order to achieve this, the Commission has identified a number of objectives that must be met. These are primarily: the protection of human health and the environment, the maintenance and enhancement of the competitiveness of the EU Chemical Industry and preventing fragmentation of the internal market. It is therefore essential to focus on these main goals, i. e. to concentrate on substances, which are placed on the market in relevant quantities.
The Commission also proposes to shift responsibility to enterprises for providing sufficient information to assess and manage the risks during the use of the substances.
Particular importance of Intermediates as driver for Innovation and competitiveness of the Chemical Industry
Intermediates are building blocks for every chemical synthesis in the Chemical Industry (for definition of intermediates, see annex 1.1). They play an indispensable role in the research and development of substances, the tailoring of synthetic routes and innovative manufacturing of chemical products. Therefore intermediates are the basis for all derived, subsequent substances, i. e. for active ingredients, high tech chemicals or any substances, which are used in chemical products.
Intermediates are exclusively used within the Chemical Industry and will not circulate outside this Industry, i. e. they are fully consumed in chemical processes to produce valuable chemicals for the European and global market.
The flexibility of chemical processes made possible by the ready availability of intermediates are the basic prerequisite for innovation and competitiveness of the Chemical Industry in Europe ultimately leading tothe development of sustainable products.
Existing EU Legislation
For many years EU Legislation has been in place to ensure the protection of human health and of the environment from possible exposure to chemical substances including intermediates, e.g.:
Content / RegulationOccupational safety framework directive on the handling of chemicals / 89/391/EC
Measures relating to the handling of chemical working substances / 98/24/EC
Special protective measures during the handling of carcinogenic substances / 90/394/EEC
Rule on the protection of workers exposed to biological agents / 90/679/EEC
Measures for improving safety and health related to nursing and expectant mothers / 92/85/EEC
Combat of air pollution from industrial plants / 84/360/EEC
Control of major-accident hazards involving dangerous substances / 96/82/EEC
Protection of groundwater against pollution caused by certain dangerous substances / 80/68/EEC
Integrated pollution prevention and control / 96/61/EEC
Transportation of dangerous goods by road / 94/55/EC
Guiding principles
According to their exclusive, clearly defined use in Chemical Industry, it is broadly accepted that intermediates should be treated differently from other substances which reach the public domain.
In the view of Industry REACH does not need to regulate intermediates at all, as long as it can be shown that they are exclusively used in chemical processes and managed safely. Chemical intermediates management comprises a direct and continued focus upon their controlled production and use. Thus manufacturers, importers and users should be able to show (on request also to Authorities), that substances which are excluded from REACH are properly managed under any other relevant legislation. So well controlled production and use of intermediates should be rewarded and should be left to the responsibility and selfcontrol of the Chemical Industry.
In this context Chemical Industry calls for pragmatic definitions, thus allowing tiered rules for exclusion or exemption of intermediates from REACH, as appropriate.
Objectives and Scope
Based on the definitions given in Annex and taking account of the existing legislation, legal precedence and available guidance, Industry believes that the different types of use of intermediates should be affected by REACH as follows:
Exclusion from REACH:
Non-isolated intermediates[1.2][*]
Isolated site-limited intermediates including storage and transport
under well controlled conditions, if processsed on:[1.3]
-site(s) of one legal entity including sites of affiliates of a company group [1.3.1]
- local site housing more than one legal entity (separate companies)[1.3.2]
Isolated non-site limited intermediates supplied directly by the manufacturer to customers for the intended use as an intermediate only. [1.4]
Though isolated intermediates are thus proposed for exclusion from REACH, the supplier is obliged to have and make available the information necessary to ensure that the substance can be handled and used safely, and that any incidents or emergencies can be dealt with in a safe and environmentally responsible manner.
Prerequisite is an internal documentation process by Industry with clear provisions, periodic internal review, and external accessibility to local and/or european authorities on request.
If intermediates produced, stored and handled under controlled conditions, as defined in Annex II section A of this paper, then it is assumed that there is no relevant exposure to humans and the environment. If those conditions of contolled use are met, then the intermediate is excluded from REACH requirements, without any further risk management and hazard information requirements.
If the conditions of controlled use, as defined in Annex II section A are not fullfilled then the requirements as defined in Annex II section B must be met, so that the intermediate can be excluded from REACH requirements.
Annex
Definitions
1.1Intermediates
A chemical substance can be defined as an intermediate if:
It is used exclusively for the synthesis of another substance(s) and it is solely manufactured for and consumed in a chemical reaction [Manual of Decisions for Implementation of 6th & 7th Amendments to 67/548/EEC on Dangerous Substances, Ref: NOTIF/3/2001].
It is used in such a way that only workers, with the knowledge of the processes, come into contact with these substances. Procedures are normally worked out to achieve adequate control of exposure [Technical Guidance Document in support of Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation (EC) No 1488/94 on risk assessment for existing substances].
It is not intentionally manufactured for any supply to the public domain.
1.2Non-isolated intermediates
Non-isolated intermediates can be defined as those which are used exclusively for the synthesis of another substance and are not intentionally removed (other than sampling) from the equipment in which they are manufactured. The equipment includes the reaction vessel in which they are manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the chemical substances pass during a continuous flow or batch process, but not including tanks or other vessels in which the substances are separately stored or transported after their manufacture. Transfer from one vessel to another via pipework, etc, for the purposes of the next reaction step, does not constitute isolation of the chemical substances [TSCA Handbook (1997)], [Lower House of the German Parliament (1989): Rationale for the Amendment of Article 16b of the German Chemicals Act], [Technical Guidance Document in support of Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation (EC) No 1488/94 on risk assessment for existing substances].
Non-isolated intermediates, as far as they could have an impact on the environment or workers, are sufficiently covered by environmental and worker protection legislation (see chapter ´Existing EU Legislation´ on front page).
1.3Isolated site-limited intermediates
An intermediate is isolated once it is removed from the process equipment, stored, or transferred to shipping containers [TSCA Handbook (1997)].
1.3.1Site(s) of one legal entity and site(s) of affiliates of a company group
Site-limited intermediates are defined as those which are manufactured, processed and stored on a site whilst awaiting further processing.
Furthermore, a site-limited intermediate may be transported to other sites owned/shared by the same legal entity or affiliates of a company group for further processing. Transport within and between sites of the same legal entity or their group affiliates will be under strict controlled conditions.
All legal entities involved will follow identical requirements on safe handling of the substance though having different (local) sites by implementing company or group wide unified standards for Occupational Health, Environmental impact and Product Stewardship.
Precedence exists in Council Directive 92/32/EEC where new substances are not subject to notification requirements when they are transferred to a different site within the same legal entity.
1.3.2Site housing more than one legal entity (separate companies)
Site-limited intermediates are manufactured, processed and isolated by one legal entity and transferred to other legal entities on the same local site for further processing. The use of the substances is entirely well controlled. Safe handling and transport of the intermediates are bound by contract between the different legal entities [TRE Support Team (2001)].
Although there is no legal precedence, it is now a common occurrence within the chemical industry for two or more legal entities to share the same facilities on a particular site. Site services, including medical care, environmental and waste management are all shared facilities and hence common standards are applied by each legal entity on site.
1.4 Isolated non-site limited intermediates supplied by the manufacturer and customers for the intended use as an intermediate only.
Non-site-limited intermediates are manufactured and isolated by one legal entity and transferred to other legal entities at a separate site, often under a toll or contract manufacture agreement. The use of the substance is entirely well controlled and bound by contract between all concerned legal entities. Transport between the sites is under strictly controlled conditions, bound by contract between the involved legal entities.
Annex
The proposals of this Annex are written in the common understanding that if the hazard of a substance is unknown, Risk Management is essential for control during handling. In cases where any potential risk has been controlled through avoidance of exposure no information on the intermediate nor registration is regarded necessary under REACH.
In addition, experience with a multitude of substances with known (eco)toxicological profile in the domain of industrial chemicals, as well as from active ingredients of pharmaceuticals etc, threshold values and uptake rates have been defined, below which substances may be considered as safe (“Thresholds of no (Toxicological) Concern”). With regard to the exposure regime associated with handling and use of substances such values should be used as cut-off levels below which no information, risk assessment and risk management is needed. These values have been established either as generic conventions to be applicable to all substances or they have to be defined for individual substances on the base of available knowledge and safety factors (e,g. UK COSHH concept). These concepts should become an integral part of decision-making in the REACH system.
A)If the conditions of controlled use meet the following cut-off levels, there is no need for any information on the intermediate nor registration under REACH.
a) Cut-off criteria:
-Substance concentration in reaction products, preparations and proximate products: < 0.1 %.
Individually lower limits can be defined if indicated (e. g. nitrosamines).
-Substance concentration in the air of the work place: < 0.1 mg/m3, reference period: 8 hours.
Individually lower limits can be defined if indicated (e. g. dioxin).
-No relevant dermal exposure (e. g. because of control measures or personal equipment).
B)If the conditions of controlled use lead to exposure exceeding the above mentioned cut-off levels, the need for further information will be decided considering control measures being already in place (e.g. protective equipment, technical standards and exposure assessments)
In particular substance-specific and group-specific limit values and/or banding values should be used as suitable tools to control exposure
-If the concentrations comply with the limit values of existing legislation (e. g. workers protection, water or soil protection), the criteria of controlled use are fulfilled.
-Where no such limit values exist, complying with group-specific or banding values (e.g. applying UK COSHH concept) fulfills the criteria of controlled use.
In case information are required, valid data should be available at least on the following end points; these data should be obtained according to generally recognized test methods, through generally recognized analogies, or based on comparable experience:
Physico-chemical properties:
-Melting temperature
-Boiling temperature
-Relative density
-Vapour pressure
-Water solubility
-Partition coefficient octanol / water
-Flash point
-Explosive properties
Toxicology:
Acute toxicity (LD50, one route)
Skin irritation
Eye irritation
Further information may be required, if a suspicion exists with regard to parameters
indicating e.g. information mutagenic/carcinogenic or skin sensitzing properties.
Control measures and protective equipment will be adapted according to this information.
As long as information may only be partly available realistic worst case assumptions should be applied to assure conditions of controlled use.
Organizational measures will be taken to ensure that companies can provide information on the handled substances at any time should the need to do so arise.
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[*] Corresponding Paragraph in the Annex.