REACH = Navigator -The Guidance on Information Requirements and Chemical Safety = Assessment

The Guidance on Information Requirements and Chemical Safety=20 Assessment

This guidance describes the information requirements under REACH with = regard=20 to substance properties, exposure, use and risk management measures, and = the=20 chemical safety assessment. It is part of a series of guidance documents = that=20 are aimed to help all stakeholders with their preparation for fulfilling = their=20 obligations under the REACH regulation.

The package of documents provides guidance on 1) the collection of = the=20 available information regarding the intrinsic properties of the = substance to be=20 registered, 2) on the assessment of this information against the = requirements=20 specified by REACH, 3) on the identification of data gaps and 4) on the=20 generation of the additional information required to fill the data = gaps.

The document package also aims at assisting industry in = conducting=20 Chemical Safety Assessments and preparing Chemical Safety Reports, when=20 required, as part of a registration dossier, as part of an authorisation = application or as part of downstream user obligations. It also sets out = the=20 basic principles for authorities preparing a risk assessment in support = of a=20 restriction proposal or a proposal to include substances into the = authorisation=20 regime, and when required as part of a Substance Evaluation.

The Guidance consists of two major parts: Concise = guidance=20 (Part=20 A to G)=20 and supporting reference guidance (Chapters=20 R.2 to R.20).

Figure 1: Structure of the = Guidance

The purpose of the concise guidance is to = support=20 the processes needed to meet the information requirements on = intrinsic=20 properties of substances to be registered, and where relevant to carry = out a=20 chemicals safety assessment. This includes information collection = processes,=20 communication processes and assessment processes. The purpose of the=20 reference guidance is to provide in-depth = scientific=20 and technical advice. The links between the concise guidance = and the=20 supporting reference guidance are illustrated in Figure 1.

Part=20 A provides an introduction to the guidance for conducting = the=20 chemical safety assessment and preparing the chemical safety report for=20 substances manufactured or imported in a quantity of 10 tonnes or more = per year=20 (Chapter=20 A.1)¹.=20 This includes an overview on the intended outcomes and main contents of = the=20 chemicals safety assessment (CSA). It also includes the overall approach = to=20 making cost-effective decisions during the iterative process of = conducting the=20 CSA, and a pathfinder to the different elements of this guidance. Chapter=20 A.2 explains the key facts needed for understanding the chemical = safety=20 assessment. The communication and tasks within the supply chain related = to the=20 chemical safety assessment are outlined in Chapter=20 A.3. Chapter=20 A.4 describes more in detail, in which situation an actor under = REACH may=20 need to carry out a CSA.

Part=20 B contains concise guidance on the hazard assessment. This = covers=20 the information requirements on intrinsic properties of a substance = under REACH,=20 including information gathering, non-testing approaches and the = so-called=20 'integrated testing strategies' for generating the relevant and required = information on each endpoint. Part B also provides concise guidance on = how to=20 characterise hazards, including where possible derivation of DNELs and = PNECs.=20 Each of the sections in Part B corresponds to the more in-depth guidance = contained in Chapters=20 R.2 to R.10.=20 This includes

Physico-chemical properties in Section=20 R.7.1=20
Derivation of no-effect-levels (DNEL) (or other = qualitative or=20 semi-quantitative measure of potency of the substance) in Chapter=20 R.8 and the corresponding chapters of integrated testing = strategies for=20 the relevant human health endpoints (Sections=20 R 7.2 to R.7.7=20 in Chapter 7a). These Sections in Chapter=20 R.7 also include information on how to derive appropriate = information for=20 classification and labelling of the substance. However, the guidance = on=20 classification and labelling itself is provided elsewhere. See current = Annex=20 VI to Directive 67/548 and future Guidance on Classification, Packaging and Labelling = related to=20 the future GHS system².=20
Derivation of predicted no-effect-effect levels (PNEC) in = Chapter=20 R.10 and the corresponding chapters of integrated testing = strategies for=20 the environment endpoints (Sections=20 R.7.8 to R.7.11 in Chapter R.7b and R.7c).These sections in Chapter=20 R.7 also include information on how to derive appropriate = information for=20 classification and labelling of the substance. However, the rules on=20 classification and labelling themselves are provided elsewhere. See = current=20 Annex VI to Directive 67/548 and future Guidance on Classification, Packaging and Labelling = related to=20 the future GHS system. Section 7.13 in Chapter 7c provides = guidance=20 related to the particular assessment approaches for hydrocarbons and=20 metals.=20
Overall framework for meeting the information requirements on = intrinsic=20 properties of substances (Chapter=20 R.2)³,=20 guidance on collection of available information (Chapter=20 R.3), evaluation of information (Chapter=20 R.4), guidance on exposure driven waiving and exposure triggered = testing=20 as well as other adaptations of information requirements (Chapter=20 R.5), in depth guidance on non-testing approaches (Chapter=20 R.6).

Part=20 C contains the concise guidance on how to assess whether or = not a=20 substance is persistent, bioaccumulative and toxic (PBT) or very = persistent and=20 very bioaccumulative (vPvB). In-depth guidance on the PBT and vPvB = assessment,=20 including emission characterisation is covered in Chapter=20 R.11.

Part=20 D details how to develop exposure scenarios and related = exposure=20 estimation. This part contains detailed workflows on how to identify = uses in the=20 supply chain, how to develop exposure scenarios and finalise them based = on the=20 iterations necessary for controlling risks. Chapter D.2 describes the = core=20 contents of an exposure scenario under REACH. It presents an overview on = the=20 most common determinants of exposure and recommends a standard format = for the=20 final exposure scenario. This also includes a list of the most common = types of=20 operational conditions (OC) and risk management measures (RMM) to be = considered=20 in ES development. Chapter=20 D.3 suggests a standard workflow of 14 steps, including the main = outputs to=20 be delivered. Chapter=20 D.4 provides guidance on developing the contents of an exposure = scenario:=20 Activities in the life cycle, description of use and title of exposure = scenario,=20 (preset) initial exposure scenarios, conditions of use for controlling = risks. Chapter=20 D.5 provides an overview on exposure estimation. This includes = guidance on=20 the role of measured data as well as a brief explanation on a number of = tools=20 available to estimate exposure. Chapter D.6 briefly describes situation = where,=20 based on initial exposure assessment, the M/I may conclude that = refinement of=20 the hazard assessment is needed, before the final exposure scenario can = be=20 derived. Chapter=20 D.7 briefly explains the risk characterisation since the risk=20 characterisation potentially triggers iterations of the initial exposure = scenario. More details on risk characterisation is provided in Part E of = the=20 guidance. Chapter=20 D.8 contains guidance on how to finalise the exposure scenario. This = includes how to integrate the operational conditions and risk management = measures for the relevant exposure routes and target groups into a = consistent=20 final exposure scenario for a specific use or uses. Finally, Chapter=20 D.9 builds the bridge to the use of exposure scenarios in the = context of the=20 CSR and the extended safety data sheet (eSDS), and makes reference to = Part F and=20 Part G of the guidance.

Part=20 D provides also links to more in-depth guidance on exposure = assessment, in particular how to describe uses, how to collect = information on=20 operational conditions and risk management measures, and how to carry = out=20 exposure estimates. This includes:

Brief general description of identified uses and giving exposure = scenarios=20 a short title (Chapter R.12)=20
Risk management measures and operational conditions for building = of=20 exposure scenarios, including guidance on how to determine the = effectiveness=20 of risk management measures and how to make use of the risk management = library=20 initially set up during the development of the current guidance (Chapter=20 R.13).=20
Occupational exposure estimation (Chapter=20 R.14)=20
Exposure estimation related to consumers (Chapter=20 R.15)=20
Exposure estimation related to the environment (Chapter=20 R.16)=20
Chapter=20 R.17 and Chapter=20 R.18⁴=20 provide guidance on exposure estimates related to life cycle stages = subsequent=20 to identified uses (releases from articles and releases from waste = life=20 stage).=20
Chapter=20 R.20 explains the terms that are essential for the understanding = of the=20 Guidance.

Part=20 E contains the guidance on the risk characterisation. In = the risk=20 characterisation, information on hazard and exposure is combined in the = risk=20 characterisation ratio or in qualitative risk characterisation. Both = types of=20 information contain uncertainty which needs to be assessed in order to = decide on=20 the robustness of the risk estimate. The uncertainty analysis is further = detailed in Chapter=20 R.19. Part E also includes guidance on qualitative risk = characterisation=20 with regard to non threshold substances.

Part=20 F details the format and requirements for preparing the = chemical=20 safety report, which documents the results of the entire chemical safety = assessment. Part F details subsections to the main headlines as laid = down in=20 section 7 of Annex 1 of REACH and provides guidance on how to present = the=20 outcome of the CSA. This includes guidance on how to use the CSR = template as=20 published on ECHAs website⁵.

Part=20 G contains the guidance on preparing the extensions to the = safety=20 data sheet (SDS). This contains information on how the exposure scenario = is=20 communicated and implemented in the supply chain. The appendices to Part = G=20 include more specific information and/or examples on the tasks of the = downstream=20 users potentially to be anticipated by the manufacturer or importer: = scaling=20 operations when the DU is evaluating whether he operates within the = boundaries=20 of the ES communicated to him; methods applied at formulators level to = process=20 the information received with exposure scenarios from suppliers into = useful=20 information for the own customers.

Figure 2 below presents an overview on the overall process of = collecting and=20 assessing existing information on the intrinsic properties of a = substance,=20 including identification of needs to generate new data. It also = describes the=20 process of chemical safety assessment additionally required for = substances=20 produced/imported in amounts of more than 10t per year.

Figure 3 below illustrates to which steps in the overall process a = particular=20 guidance element is related to.

Figure 2: Overall process related to = information=20 requirements and chemicals safety assessment under REACH.

Figure 3: Reference between the process steps = and the=20 guidance elements

RIP 3.2 structure

Part A - Introduction to the Guidance=20 Document
[ download PDF version - PART A 3D"pdf ] [ download ZIP version - PART A 3D"zip ]

Part B - Hazard = Assessment
[ download PDF version - PART B 3D"pdf ] [ download ZIP version - PART B 3D"zip ]

Part C - PBT Assessment
[ = download PDF version - PART C 3D"pdf ] [ download ZIP version - PART C 3D"zip ]

Part D - Exposure Scenario = Building
[=20 download PDF version - PART D 3D"pdf ] [ download ZIP version - PART D 3D"zip ]

Part E - Risk = Characterisation
[ download PDF version - PART E 3D"pdf ] [ download ZIP version - PART E 3D"zip ]

Part F - Chemicals Safety = Report
[ download PDF version - PART F 3D"pdf ] [ download ZIP version - PART F 3D"zip ]

Part G - Extension of = SDS
[ download PDF version - PART G 3D"pdf ] [ download ZIP version - PART G 3D"zip ]

Information = requirements
[ download PDF version - Chapter R.2 3D"pdf ] [ download ZIP version - Chapter R.2 3D"zip ]

Information gathering
[ = download PDF version - Chapter R.3 3D"pdf ] [ download ZIP version - Chapter R.3 3D"zip ]

Evaluation of available information=20
[ download PDF version - Chapter R.4 3D"pdf ] [ download ZIP version - Chapter R.4 3D"zip ]

Adaptation of Information=20 requirements
[ download PDF version - Chapter R.5 3D"pdf ] [ download ZIP version - Chapter R.5 3D"zip ]

QSARs and grouping of = chemicals
[ download PDF version - Chapter R.6 3D"pdf ] [ download ZIP version - Chapter R.6 3D"zip ]

Endpoint specific = guidance
[ download PDF version - Chapter R.7a 3D"pdf ] [ download ZIP version - Chapter R.7a 3D"zip ]
[ download PDF version - Chapter R.7b 3D"pdf ] [ download ZIP version - Chapter R.7b 3D"zip ]
[ download PDF version - Chapter R.7c 3D"pdf ] [ download ZIP version - Chapter R.7c 3D"zip ]

Characterisation of dose = [concentration] -=20 response for human health
[ download PDF version - Chapter R.8 3D"pdf ] [ download ZIP version - Chapter R.8 3D"zip ]

Physico-chemical = hazards
[ download PDF version - Chapter R.9 3D"pdf ] [ download ZIP version - Chapter R.9 3D"zip ]

Characterisation of dose = [concentration] -=20 response for environment
[ download PDF version - Chapter R.10 3D"pdf ] [ download ZIP version - Chapter R.10 3D"zip ]

PBT Assessment
[ download PDF version - Chapter R.11 3D"pdf ] [ download ZIP version - Chapter R.11 3D"zip ]

Use descriptor = system
[ download PDF version - Chapter R.12 3D"pdf ] [ download ZIP version - Chapter R.12 3D"zip ]

Risk management measures and = operational=20 conditions
[ download PDF version - Chapter R.13 3D"pdf ] [ download ZIP version - Chapter R.13 3D"zip ]

Occupational exposure = estimation
[=20 download PDF version - Chapter R.14 3D"pdf ] [ download ZIP version - Chapter R.14 3D"zip =20 ]

Consumer exposure = estimation
[ download PDF version - Chapter R.15 3D"pdf ] [ download ZIP version - Chapter R.15 3D"zip =20 ]

Environmental exposure=20 estimation
[ download PDF version - Chapter R.16 3D"pdf ] [ download ZIP version - Chapter R.16 3D"zip =20 ]

Estimation of exposure from=20 articles
[ download PDF version - Chapter R.17 3D"pdf ] [ download ZIP version - Chapter R.17 3D"zip =20 ]

Estimation of exposure from waste=20 life
[ download PDF version - Chapter R.18 3D"pdf ] [ download ZIP version - Chapter R.18 3D"zip =20 ]

Uncertainty analysis
[ = download PDF version - Chapter R.19 3D"pdf ] [ download ZIP version - Chapter R.19 3D"zip =20 ]

Table of terms
[ download PDF version - Chapter R.20 3D"pdf ] [ download ZIP version - Chapter R.20 3D"zip =20 ]

1. Guidance on collection and = evaluation of=20 information related to use and exposure required according to Annex VI = point 6=20 for substances between 1 and 10 t/y is not covered in this guidance. For = information consult the Guidance on Registration.

2.=20 Guidance under development, to be expected in first half 2009. =

3. The current Chapter R.2 will be replaced with a version = aligned to=20 Part B, once endorsed by the meeting of the REACH Competent Authorities = in June=20 2008.

4. Chapter R.18 on exposure = estimation for the=20 waste life stage will be added to the guidance after endorsement by the = REACH=20 Competent Authority meeting in June 2008.

5. The=20 current Guidance Part F will be replaced with an extended version = (integrating=20 the CSR template being developed by ECHA), once endorsed by the REACH = Competent=20 Authority meeting in June 2008.