RIP 3.2-1aSDS and CSA of Preparations
Considerations on Safety Data Sheets and Chemical Safety Assessments of Preparations
[cdj1]Final report
“Technical Guidance Document on preparing the Chemical Safety Report under REACH – Scoping Study – Phase 1 A (REACH Implementation Project 3.2-1A)”
“Technical Guidance Document on preparing the Chemical Safety Report under REACH – Preliminary Guidance Document on preparing the Chemical Safety Assessment under REACH –Phase 1B (REACH Implementation Project 3.2-1B)”
Service Contract Numbers 22551-2004-12 F1SC ISP BE and 22552-2004-12 F1SC ISP BE
Preface
Within the context of the proposed EU Chemicals policy, REACH[1], the European Commission has initiated REACH Implementation Projects (RIPs) with the intention of developing tools and guidance for the new legislation. REACH Implementation Project No. 3 covers a suite of individual projects all aimed at developing guidance for industry on various aspects of REACH. Under the RIP No. 3.2, a Technical Guidance Document and supporting IT application on conducting the Chemical Safety Assessment and preparing the Chemical Safety Report shall be developed.
This report is part of the deliverables from the Scoping Study for Technical Guidance Document on preparing the Chemical Safety Report under REACH (REACH Implementation Project 3.2-1A Lot 1; Commission service contract number –22551-2004-12 F1SC ISP BE) and the Preliminary .Guidance Document on preparing the Chemical Safety Assessment under REACH (REACH Implementation Project 3.2-1B Lot 2; Commission service contract number –22552-2004-12 F1SC ISP BE).
The scoping study was co-ordinated by Cefic (the contractor) and carried out by experts from Cefic, ECETOC, RIVM, The Federal Institute for Risk Assessment (BfR), Federal Institute for Occupational Safety and Health (BAuA), Ökopol, DHI Water & Environment and TNO Chemistry, within the time frame of January to July 2005.
In writing this report the Consortium received valuable input from members of the Stakeholder Experts Group nominated by the Commission to discuss the progress and outcome of the project.
The views expressed in this report are the sole responsibility of the authors. The content does not reflect any legal interpretation of the Commission’s proposal for a Regulation on REACH1 nor does it necessarily reflect the opinion of the Commission or it’s services.
1 Proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}”. COM(2003) 644 final, Brussels.
CONTENTS
LIST OF ABBREVIATIONS
1Introduction
2Current industry approach
3REACH requirements on preparations
3.1Safety Data Sheets for preparations
3.2Exposure Scenarios for preparations
3.3Chemical Safety Assessment for preparations
4Some practical solutions
4.1Composite reciprocal DNEL/PNEC
4.2Key critical component
4.3Risk-base Emission Thresholds (RETs)
4.4More general comments on both CEPE and Henkel approach
4.5Other ways to simplify and rationalise CSA/SDS approach for preparations
5Other information on preparations down the supply chain
6CONCLUSIONS AND RECOMMANDATIONS
Annex I: Example of CEPE approach for preparations applied to solvent borne primer
Annex II: Concept for exposure scenarios for preparations in the workplace
LIST OF ABBREVIATIONS...... 4
1Introduction...... 5
2Current industry approach...... 5
3REACH requirements on preparations...... 6
3.1Safety Data Sheets for preparations...... 6
3.2Exposure Scenarios for preparations...... 7
3.3Chemical Safety Assessment for preparations...... 8
4Some practical solutions...... 10
4.1Composite reciprocal DNEL/PNEC...... 10
4.2Key critical component...... 12
4.3Risk-base Emission Thresholds (RETs)...... 12
4.4More general comments on both CEPE and Henkel approach...... 13
4.5Other ways to simplify and rationalise CSA/SDS approach for preparations...... 13
5Other information on preparations down the supply chain...... 14
6CONCLUSIONS AND RECOMMANDATIONS...... 15
Annex I: Example of CEPE approach for preparations applied to solvent borne primer...... 16
Annex II: Concept for exposure scenarios for preparations in the workplace...... 18
FIGURES
Figure 1: Workflow for Preparation
Figure 1: Workflow for Preparation...... 8
LIST OF ABBREVIATIONS
C&LClassification and Labelling
CEPEEuropean Council of the Paint, Printing Ink and Artists‘Colours Industry
CSAChemical Safety Assessment
CSRChemical Safety Report
DNELDerived No-Effect Level
DUDownstream User
ESExposure Scenario
extSDSextended Safety Data Sheet
GEV Generic Exposure Value
GDEV Generic Dermal Exposure Value
M/IManufacturer/Importer
PBTPersistent, Bioaccumulative, Toxic
PECPredicted Environmental Concentration
PNECPredicted No-Effect Concentration
RCR Risk Characterisation Ratio
RET Risk-based Emission Threshold
RIP Reach Implementation Project
RMMRisk Management Measure
SDSSafety Data Sheet
SEG Stakeholder Expert Group
TRATargeted Risk Assessment
WPWork Package (of RIP 3.2)
WWTPWaste Water Treatment Plant
1Introduction
In the scoping studies under RIP 3.2 the main emphasis is on substances. In this document a number a scoping issues are brought together in relation to preparations.
Based on the text of the REACH proposal the need/possibilities for Chemical Safety Assessment (CSA) for preparations will be reviewed. As a follow up of the RIP 3.2 reports on General Framework of Exposure Scenarios Scoping study( of RIP 3.2 1a-WP1) and the Chemical Safety Assessment Scoping studies (of RIP 3.2 1a-WP2) it will be described when exposure scenarios (ESs) could beneficially be developed for preparations and which approaches are feasible for a CSA for preparations.
The industry partners in the Consortium and members of the Stakeholder Experts Group (SEG) have provided information on their present practice of assessing preparations and on how they presently develop adequate Safety Data Sheets (SDSs). Furthermore for this document, existing practices of assessing preparations under other regulations (pesticides, biocides, pharmaceuticals) have been explored.
Preparations require flexibility and adaptation of standard RA methods. Therefore some preliminary guidance on a CSA for preparations will be given, however this needs further development in Phase 2 of RIP 3.2.
2Current industry approach
Under the current EU legislation the hazard of preparations is evaluated on the basis of the criteria led down in Directive 1999/45/CE on the classification, packaging and labelling of dangerous preparations and modified by Directive 2001/60/EC. These criteria include calculations methods to determine the classification and labelling (C&L) of the preparation based on the labelling and classification C&L of the individual substances. In these calculation methods a summation of the C&L is used taking into account the percentage of the substances in the preparation. As the same C&L for systemic effects can be based on different toxicological endpoints (e.g. liver or kidney effects leading to R48) the calculation method for summation does not apply.
The person responsible for placing on the market a dangerous preparation needs to provide an SDS.
In addition on request of a professional user an SDS shall be provided containing proportionate information for preparations not classified as dangerous but containing in an individual concentration of > 1 % by weight for non-gaseous preparations and >0 ,2% by volume for gaseous preparations at least:
- one substance posing health or environmental hazards, or
- one substance for which there are Community workplace exposure limits.
Directive 91/155/EEC, as amended by Directives 93/112/EEC and Directive 2001/58/EC, sets out the requirements for the information which should be included in the SDS.
In today’s practice, industry in preparing the SDS for a preparation will collect the SDS’s for the (dangerous) substances in that preparation and makes an expert judgment which substance(s) constitute the highest potential risk. In this semi-quantitative judgment the hazardous properties, the exposure potential as defined by their physico-chemical attributes, the percentage in the preparation and foreseen use of the substances are considered. Thus the resulting SDS of the preparation is based on the protection against substance(s) with the highest risk potential.
To protect workers the exposure limits of substances in the preparation of which the exposure could be relevant are mentioned in the SDS. Furthermore, in the workplace Directive 98/24/EC applies and hazardous chemical agents in the context of this Directive include both substances and preparations. As with any chemical in the workplace exposure to substances in preparations are assessment by (semi)quantitative methods and/or measurements. The acceptable exposure to several substances which have similar toxicological effects on the same target organ is assessed by the additivity formula (sum of relative exposure to each substance should be less than one).
3REACH requirements on preparations
In case of preparations, Art. 29 (2) (see for text below) of the REACH proposal allows the option of developing a CSA for the preparation as a whole instead of for all substances in the preparation to make it easier to derive DNELs and PNECs and better reflect the hazards and control measures for the preparation itself. The method for performing a CSA for preparations is set out in Annex Ib.
Although REACH requires an SDS for a dangerous preparation, it does not require a CSA, or the establishment of DNELs/PNECs for that preparation.; A CSA for a preparation is an optional route for establishing an SDS.
Therefore the real starting point for considering the requirements for a preparation under REACH should the preparation of the SDS.
3.1Safety Data Sheets for preparations
REACH Article 29 - Requirements for Safety Data Sheets
1. Where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC, the person responsible for placing that substance or preparations on the market, whether the manufacturer, importer, downstream user or distributor, shall supply the recipient, who is a downstream user or distributor of the substance or preparation, with a safety data sheet compiled in accordance with Annex Ia.
2. Any actor in the supply chain who is required, under Articles 13 or 34, to carry out a chemical safety assessment as part of his registration for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment.
If the safety data sheet is developed for a preparation, the actor in the supply chain may prepare a chemical safety assessment for the preparation in accordance with Annex Ib. In that case, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance in the preparation.
3. Where a preparation does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains in an individual concentration of ≥ 1 % by weight for non-gaseous preparations and≥ 0.2 % by volume for gaseous preparations at least one substance posing health or environmental hazards, or one substance for which there are Community workplace exposure limits, the person who is responsible for placing that preparation on the market, whether the manufacturer, importer, downstream user or distributor, shall supply, at the request of a downstream user, a safety data sheet compiled in accordance with Annex Ia.
4.The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of health, safety and the environment, unless requested by a downstream user.
5. The safety data sheet shall be supplied, if a downstream user so requests, in the official languages of the Member States in which the substance or preparation is placed on the market. Annex Ia - Guide to the compilation of safety data sheets
Preparations produced by DU (e.g. paints, inks, adhesives, household cleaners etc) may be constituted from a great number of substances and other preparations. These last preparations may consist again out of a large number of substances. Adding all up, the number of substances in some preparations may be up to 40 to 60.
Considering that a CSA need not to be performed for substances present in a preparation below any of the concentration limits defined in Art. 13 (2) (see text below) and if only a few components cause the preparation to be classified, it may be easier to ensure that the information in the SDS for the preparation is consistent with the SDSs for the relevant substances.For this approach to be workable, the information in each of the substance SDSs has to be of a consistent nature; to be expressed in the same way; and capable of being combined to produce an overall understandable SDS for the preparation.
This includes eventually merging the ESs for a few dangerous components into a consolidated ES for the preparation i.e. to use their extended SDS (extSDS) to generate an extSDS for the preparation (see figure 1).
Figure 1: Workflow for Preparation
3.2Exposure Scenarios for preparations
Under REACH, the M/I who supplies a dangerous substance should be aware that it is used in preparations (identified uses). Therefore the substance and its concentration in the preparation should already have been taken into account in the CSA and thus a relevantn ES should be available in the annex to the SDS of that substance.
When the preparation also contains other several dangerous substances, the formulator needs to work out a SDS for the preparation, consolidating the hazard information, the DNELs/PNECs and the ESs of different substances into the SDS for the preparation.
The ES for a preparation should not simply list the individual ESs for each of the individual components, but be developed by taking into account the way each substance appears in the preparation (matrix) and its potential exposure. Nevertheless, calculations may not be needed for developing an ES for a preparation, as it could be just a compilationan integration of risk management measures (RMMs) specified in the ESs for the individual components provided that no contradictory RMMs are given. As a result,
This approach, however, takes no account of the principles of additivity, which may lead to the effects of a preparation being greater than those of the individual substances alone.
Thus, the RMMs that will need to be applied by anyone using a preparation may, will almost always be more stringent than that recommended by the M/I of the substance, because it has to take into account the properties of other substances in the preparation.
This is demonstrated in the paint scenario in the RIP 3.2 report on General Framework of Exposure Scenarios Scoping documentstudy Annex 8, where 95% removal of turpentine in an oil filter and 84% of pigment in a filter, are seen as effective RMMs on the basis of reverse risk calculations, but will this be sufficient when both are present? Therefore caution should be taken in just adding RMMs without any considerations of combined hazards and/or exposures.
As there is no agreed detailed guidance on how to derive an appropriate ES for individual substances, further guidance for combining ESs for preparations can presently not be given and should be considered in Phase 2 of RIP 3.2.
Figure 1: Workflow for Preparation
3.3Chemical Safety Assessment for preparations
REACH Article 13: Chemical safety report and duty to apply and recommend risk reduction measures
1. Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter if the registrant manufactures or imports such a substance in quantities of 10 tonnes or more per year.
The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a preparation or a group of substances.
2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a preparation if the concentration of the substance in the preparation is less than the lowest of any of the following:
(a) the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC;
(b) the concentration limits given in Annex I to Directive 67/548/EEC;
(c) the concentration limits given in Part B of Annex II to Directive 1999/45/EC;
(d) the concentration limits given in Part B of Annex III to Directive 1999/45/EC;
(e) the concentration limits given in an agreed entry in the classification and labelling inventory established under Title X;
(f) 0.1%, if the substance meets the criteria in Annex XII.
REACH ANNEX Ib: Chemical safety assessments for preparations
A chemical safety assessment for a preparation shall be conducted in accordance with
Annex I with the following modifications:
1. INFORMATION BASE
The chemical safety assessment for a preparation shall be based on the information on the individual substances in the preparation contained in the technical dossier and/or the information communicated by the supplier in the safety data sheet. It shall also be based on the information available on the preparation itself.
2. HAZARD ASSESSMENTS
The hazard assessments (human health, human health for physicochemical properties and environmental) shall be carried out in accordance with Sections 1, 2 and 3 with the following alterations:
(a) For the evaluation of data step(s), any relevant data for the preparation, the classification for each substance in the preparation and any specific concentration limits for each substance in the preparation shall be presented.
(b) For the classification and labelling step, the classification and labelling for the preparation in accordance with European Parliament and Council Directive 1999/45/EC shall be presented and justified.
(c) For the derivation of derived no-effect levels (DNELs), the DNEL for each substance in the preparation with an appropriate reference to the safety data sheet of the supplier shall be listed, as well as the DNEL derived for the preparation, with a justification on their derivation. In lack of any information to the contrary, then additivity of effects shall be assumed. The DNELs for the preparation can then be calculated for each route of exposure and each exposure scenario as a weighted average of the DNELs for each substance in the preparation, with the weights being the fraction of the exposure to the substance in the preparation to the total exposure to all substances in the preparation.
(d) For the derivation of the predicted no-effect concentrations (PNECs), the PNEC for each substance in the preparation with an appropriate reference to the safety data sheet of the supplier shall be listed, as well as the PNECs derived for the preparation, with a justification on their derivation. In lack of any information to the contrary, then additivity of effects shall be assumed. The PNECs for the preparation can then be calculated for each environmental sphere and each exposure scenario as a weighted average of the PNECs for each substance in the preparation, with the weights being the fraction of the exposure to the substance in the preparation to the total exposure to all substances in the preparation.