ADDENDUM
TO THE GUIDANCE ON ANNEX XV FOR RESTRICTIONS AND TO THE GUIDANCE ON SOCIO-ECONOMIC ANALYSIS (SEA) – RESTRICTIONS
EXPLANATORY NOTE
FORMAT OF ANNEX XV RESTRICTION REPORT
1October, 2009
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EXPLANATORY NOTE
Introduction
This format for an Annex XV restriction report replacesAppendixes I “Format for Restriction report“and II “Information on how to fillin the Annex XV restriction report” of theGuidance on Annex XV for restrictions and section 5.2 “Reporting format” of theGuidance on Socio-economic Analysis (SEA) –- Restrictionsrespectively.
The aim of merging the two separate formats is to ensure that the reporting format is consistent and follows both the requirements set out in Title VIII andAnnex XV of the REACH Regulation and the needs of decision making. The documentation of the information on hazard and risks in this formatfollows the relevant parts of Annex I of REACH, theGuidance on Information requirements and CSA and the CSA template. This single format covers also the documentation of SEA information (based on Annex XVI of the REACH Regulation and theGuidanceonSEA –Restrictions).Compared to the format included in the Guidance on Annex XV for restrictions, theformat below contains more detailed subheadings for all main headings, not only for information on hazard and risk.
The new combined format streamlines and clarifieshow to document all relevant information in an Annex XV restriction report. It does not to add newrequirements or remove existing ones in the two formats it substitutes. In other words, the purpose is merely to assist Competent Authorities and ECHA (in case it receives a request from the Commission) in documenting the proposals for restrictions in a clear and transparent way.
This reporting format outlines how the final outcome of the work on an Annex XV report for restriction is to be documented. It does not describe the process, including the iterations that have been taken during the process of preparing the Annex XV restriction report. This process is described in the guidance documents.It should be stressed that the reporting must contain sufficient information allowing the reader to follow the logic, including the relevant assumptions and decisions made during the preparation of the restriction proposal. To assure this, relevant further information supporting any part of the report may be provided as annexes. Any confidentialinformation should always be documented in separate annexes to ensure good administrative practice.
The reporting format includes explanations in cases where further clarification was considered helpful.
Correspondence between the guidance documents and the reporting format
Figures 1 and 2 illustrate which sections of the two guidance documents are relevant for developing the different parts of an Annex XV report. Figure 1 gives an overview of the association between the sections of the two guidance documents and the reporting format. Figure 2 focuses onsection E (Justification why a restriction is the most appropriate Community-wide measure).Both guidance documents support the development of section E andthe correspondence is more complex than for the other sections.The figures refer only to the most central sections of the guidance documents for each report heading. To get a more comprehensive picture of the restriction report and process it is recommended that persons preparing restriction reports familiarise themselves with the guidance documents as a whole and not only the sections referred to one by one.
It should be noted that an assessment of the socio-economic impacts of the proposed restriction (5th heading in Annex XV, section F in the format) is a highly recommended but not a mandatory part of an Annex XV report. However,the justification for restriction on a Community level (the 4th heading in Annex XV, section E in the format) is mandatory. In particular, the assessment of the identified restriction and other risk management options against the effectiveness criteria calls for information on and the assessment of effects on human health and the environment as well as the costs to the different actors. SEA provides an effective approach to collect, evaluate and present such information. The Guidance on SEA – Restrictionscovers the use of the SEA approach and information for four purposes:
- Justification that Community-wide action is required;
- Assessing whether the proposed restriction is the most appropriate Community-wide action compared to other risk management options;
- Refining the scope, timeline and conditions of the proposed restriction;
- Assessing the proposed restriction in terms of net benefits to human health and the environment and the net costs to the actors affected and society as a whole.
Therefore theGuidance on SEA – Restrictionsis helpful during the preparation of Annex XV report on restrictions even if section F would be prepared only partially or not at all.
In both Figures 1 and 2 the column on the left gives the references to the Guidance on Annex XV for restrictionsand the column on the right gives the references to theGuidance on SEA – Restrictions. The middle column includes the main headings of the reporting format.
Figure 1: Correspondence between the reporting format and relevant sections in the Guidance on Annex XV for restrictionsand the Guidance on SEA – Restrictions
Figure 2:Correspondence betweenSection E (Justification why a restriction is the most appropriate Community-wide measure) and relevant sections in the Guidance on Annex XV for restrictionsand the Guidance on SEA - Restrictions
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ANNEX XV RESTRICTION REPORT FORMAT
FORMAT OF ANNEX XV RESTRICTION REPORT
ANNEX XV RESTRICTION REPORT
PROPOSAL FOR A RESTRICTION
SUBSTANCE NAME(S): [Insert substance name(s)]
IUPAC Name(s): [insert iupac name(s)]
EC NUMBER(S): [insert ec number]
CAS NUMBER(S): [insert cas number]
CONTACT DETAILS OF THE DOSSIER SUBMITTER: [insert contact details]
VERSION NUMBER: [insert version number]DATE: [insert date]
proposal for a restriction
A. Proposal
A.1 Proposedrestriction(s)
The proposed restriction(s) should be expressed in a form of Annex XVII entry.
A.1.1 The identity of the substance(s)
-Give here the substance or the groups of substances subject to restriction (from B1.1-B.1.3).
- Substance name(s)
- IUPAC name(s)
- EC number (s)
- CAS number (s)
A.1.2 Scope and conditions of restriction(s)
-the scope of restriction(s) manufacturing, placing on the market (in general or for specified use(s)) and/or (specified) use(s) of the substance on its own, in a preparation or in an article(from E.5);
-Any derogations, conditions and/or monitoring obligations (from E.5)
A.2 Summary of the justification
Summarize (or copy) here the relevant information given in the following sections: B.1.4, B.11, D.4 and E.5
A.2.1Identified hazard and risk
- Description of and justification for targeting of the information on hazard and exposure
- Description of the risk to be addressed by the proposed restriction
- Information on hazard(s)
- Information on emissions and exposures
- Characterisation of risk(s)
- Which activities (manufacture an/or use(s) as such, in mixtures or in articles or waste stage resulting from these) result in exposures causing the risk
- Which human populations or environmental compartments are at risk
- Evidence that the risk management measures and operational condition implemented and recommended by the manufacturers and/or importers are not sufficient
- Evidence that the existing regulatory risk management instruments are not sufficient
A.2.2 Justification that action is required on aCommunity-wide basis
A.2.3 Justification that the proposed restriction is the most appropriate Community-wide measure
- Effectiveness in reducing the identified risks,
- Proportionality to the risks
- Practicality, including enforceability
- Monitorability
B. Information on hazard and risk
(Based on sections 4 and 5.2 ofthe Guidance on Annex XV for restrictionand on section 2.3 of theGuidance on SEA - Restrictions)
The documentation of information on hazard and risks should follow the relevant parts of Annex I of the REACH Regulation and of the Guidance on Information requirements andChemical Safety Assessment (CSA). Therefore, the format for this section includes all the main headings of a Chemical Safety Report (CSR) template, part B.It is thus recommended to follow the CSR template as the subheadings and tables in the CSR template can be used whenever relevant for the restriction proposal. Guidance on information requirements and chemical safety assessment, Appendix to Part F, CSR Template with explanation gives further advice how the information could be structured.Note also that where relevant, the information can be extracted directly from the IUCLID 5 dossier. However, sub-sections B.9 (Exposure assessment) and B.10 (Risk characterisation) aim to assist the documentation of more combined and generalised information than what is required from the registrant’s CSA and, therefore,they differ from the CSR template.
Some of the main headingsfrom B.3 to B.8 may not be relevant for any particular case. This depends on the nature/scope of the proposal. Where a heading is not needed, state ‘not relevant for this proposal’ under the heading. It is recommended to document under sections B.4-B.8 on fate and hazard all relevant data and, where appropriate, to document also the sources of information. The relevant sections should also give reasoning if the interpretation of studies differs from those given in available CSRsin the registration dossiers.
If the proposal is targeted, give the reasoning for it.Targeting can be based on hazard, use and/or exposure information.If the proposalcovers several substances (grouping of substances) give sufficient information of all substances covered by the proposal.
B.1 Identity of the substance(s) and physical and chemical properties
If the restriction proposal covers more than one substance (i.e. grouping of substances) a justification for grouping should be given here. Give also registration numbers where available.
B.1.1 Name and other identifiers of the substance(s)
B.1.2 Composition of the substance(s)
B.1.3 Physicochemical properties
B.1.4 Justification for grouping
(Based on section 4.2.3 of the Guidance on Annex XV for restrictions)
B.2 Manufacture and uses
Document the available information on manufacture, import, export and uses of the substance on its own, in preparation or in articles. Describe all stages of the life-cycle of the substance resulting from the manufacture and uses. If appropriate use the descriptor system as described in the Guidance on information requirements and chemical safety assessment, Volume 2: Guidance on Chemical safety report.
B.2.1 Manufacture, import and export of a substance
Report tonnage manufactured, imported or exported. Document available information about the past trends in manufacture, import and export and, where relevant, location and number of manufacturers. Where relevant, document here also information on import and export of articles containing the substance.
The future trends: see section E.1.1.
B.2.2 Uses
Document here all available information on uses of a substance in order to get an overview of all uses of the substance. Uses may cover use of the substance on its own or in preparation(s) and also uses of articles containing the substance.
For uses for which a restriction is being proposed, document available information about the tonnage and past trends in use of the substance and, where relevant, location and number of users of the substance The future trends: see section E.1.1.
B.2.3 Uses advised against by the registrants
Document here the uses advised against by the registrants which are recorded in the CSRs. Give also the justifications given by the registrants.
B.2.4 Description of targeting
(Based on section 5.2.1 of the Guidance on Annex XV for restrictions)
In case of targeting, listthe uses which are considered further in the report and give reasons for targeting.
B.3 Classification and labelling
B.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)
B.3.2 Classification and labelling in classification and labelling inventory/
Industry’s self classification(s) and labelling
B.4 Environmental fate properties
Report here relevant environmental fate properties. Use only the subheadings relevant for the case.
B.4.1 Degradation
B.4.2 Environmental distribution
B 4.3 Bioaccumulation
B.4.4 Secondary poisoning
B.5 Human health hazard assessment
Report here relevant toxic end points.Use only the subheadings relevant for the case.
B.5.1 Toxicokinetics (absorption, metabolism, distribution and elimination)
B 5.2 Acute toxicity
B 5.3 Irritation
B 5.4 Corrosivity
B 5.5 Sensitisation
B 5.6 Repeated dosed toxicity
B 5.7 Mutagenicity
B 5.8 Carcinogenicity
B 5.9 Toxicity for reproduction
B 5.10 Other effects
B 5.11 Derivation of DNEL(s)/DMEL(s)
B.6 Human health hazard assessment of physico-chemical properties
Report here relevant physico-chemical end points.Use only the subheadings relevant for the case.
B 6.1 Explosivity
B 6.2 Flammability
B 6.3 Oxidising potential
B.7 Environmental hazard assessment
Report here relevant environmental hazard end points.Use only the subheadings relevant for the case.
B 7.1 Aquatic compartment (including sediments)
B 7.2 Terrestrial compartment
B 7.3 Atmospheric compartment
B 7.4 Microbiological activity in sewage treatment systems
B 7.5 Non compartment specific effects relevant for the food chain (secondary poisoning)
B.8 PBT and vPvB assessment
Report here the conclusion of the assessment with relevant justifications.Use only the subheadings relevant for the case.
B 8.1 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII
B 8.2 Emission Characterisation
B.9 Exposure assessment
(Based on section 5.2.3 of the Guidance on Annex XV for restrictions)
Document in sufficient detailthe exposure assessment of manufacture and all uses and the relevant life-cycle stages(including use of articles containing the substance and all relevant waste stages) identified in chapter B.2.4and for which a restriction is proposed.Describe where available, information of the total amount of emissions in order to get a better picture of the proposed restriction. Document the available information on the implemented and recommended risk management measures and operational conditions of the manufacture and of each use described in the restriction proposal (exposure scenarios). Document also the existing legal requirements (based on section 5.2.3.1of the Guidance on Annex XV for restrictions) that aim at reducing emissions and exposures.The exposure estimation needs to take into account of the implemented operational conditions and risk management measures. Report the assessment of all relevant exposures to different human populations (workers, consumers, humans exposed via the environment) and to different environment compartments. Describe the situations giving grounds for risk to human health and/or the environment. Report also, where relevant, when the interpretations differ from the ones in CSRs. When the restriction proposal is based on combined human exposure and/or aggregated or total exposure using estimates of total emissions, describe the situation in sufficient detail.
B.9.1 General discussion on releases and exposure
B.9.1.1 Summary of the existing legal requirements
B.9.1.2 Summary of the effectiveness of the implemented operational conditions and risk management measures
B.9.2 Manufacturing
B.9.2.1 Occupational exposure
B.9.2.2 Environmental release
B.9.3 “Use 1” …
B.9.3.1 General information
B.9.3.2 Exposure estimation
B.9.3.2.1 Workers exposure
B.9.3.2.2 Consumer exposure
B 9.3.2.3 Indirect exposure of humans via the environment
B.9.3.2.4 Environmental exposure
B.9.x Add subheadings if more than one use is described and change the following subheadings accordingly
B.9.4 Other sources (for example natural sources, unintentional releases)
B.9.5 Overall environmental exposure assessment
B.9.6 Combined human exposure assessment
B.10 Risk characterisation
(Based on section 5.2.3 of the Guidance on Annex XV for restriction)
Describe risk characterisation results and identify risks which are not sufficiently managed. This should be done for all relevant combinations of uses, exposure routes, exposure durations and human populations / environmental compartments.If possible, give here supplementary information on e.g number of exposed workers and/or consumers, number of affected industrial sites, expert judgement on geographical relevance of pollution, demographic data of impacted area. If risk characterisation is performed for manufacture or uses which are not suggested to be restricted these characterisations should be included for completeness.
B.10.1 Manufacturing/’Use 1’ etc.(Use the relevant headings from section B.9)
B.10.1.1 Human health
B.10.1.1.1 Workers
B.10.1.1.2 Consumers
B.10.1.1.3 Indirect exposure of humans via the environment
B.10.1.1.4 Combined exposure
B.10.1.2 Environment
B.10.1.2.1 Aquatic compartment (including sediment and secondary poisoning)
B.10.1.2.2 Terrestrial compartment (including secondary poisoning)
B.10.1.2.3 Atmospheric compartment
B.10.1.2.4 Microbiological activity in sewage treatment systems
B.10.x Add subheadings accordingly from section B.9 if needed e.g. 10.2. etc.
B.11 Summary on hazard and risk
Give here a summary of the current identified risk(s). Describe hazard end-point(s), human population(s) and/or environment compartment of concern. Describe which activities (manufacture, placing on the market, usesas such, in mixtures or in articles or waste stage resulting from these causes the exposure given rise to therisk. Give also the evidence that the current risk management measures and operational conditions are not sufficient and that the existing regulatory risk management instruments are not sufficient. Possible grouping and/or targeting should be described here. In this section, describe the situation concerning currenthazard and risk. This summary describes thus also the baseline as of today and is the starting point forsection E.1.1.
C.Available information on alternatives
(Based on section 5.5. of the Guidance on Annex XV for restrictions. Sections 2.4, 2.5 and 3 ofGuidance on SEA – Restrictions include aspects that support defining what to consider and document on alternatives, also other parts of this guidance support the documentation.)
Document all available information on alternative substances and techniques. This information is used when assessing the human health and/or environmental effects and costs of the proposed restriction and other risk management options.
C.1 Identification of potential alternative substances and techniques
(Based on sections 5.5.3 and 5.5.3.1 of the Guidance on Annex XV for restrictionsand sections 2.4 and 3.1-3.3 of the Guidance on SEA – Restrictions)
Describe here the first screening of the alternatives including alternatives which have been considered but not discussed further in the following sections.
C.2 Assessment of alternative 1[1]
Copy from C.1 a short description of alternative 1
C.2.1 Availability of alternative 1
(Based on section 5.5.3.2 of the Guidance on Annex XV for restrictions)
C.2.2Human health risks related to alternative1
(Based on section 5.5.3.2 of the Guidance on Annex XV for restrictionsand section 3.4 of the Guidance on SEA – Restrictions)
C.2.3 Environment risks related to alternative 1