The CSR for a monomer has to fulfill the same requirements as for any other substance. This is evident for Step 1 to 4 where the intrinsic properties are evaluated and the DNEL/PNEC is derived. Except if a polymer has already been notified under 67/548/EEC for the same tonnage band, than this is not required anymore. Only the possible exposure in the EU should be taken into account in the CSR. If the monomer has hazardous properties, exposure scenarios for workplace, consumer and environment have to be derived for the identified uses and for all life-stages.
For a monomer such uses might for example be defined as the "production of polymers" (different scenarios for different processes, different scenarios for different fields of application?) or the use as a "reactive thinner".
If the producer of a monomer cannot propose a safe exposure scenario for a certain use he will not include this use as an identified use for the monomer (e.g. use of certain monomers for packaging of food).

A CSA is required for substances classified as dangerous to human health or the environment in the EU. You are advised to check the most recent RIP 3.2 and 3.3 on this subject which provide extensive guidance on the subject o preparing all aspects of a CSA.

The key to effective communication with DU’s is related to the transfer of the necessary information from the CSA by preparing an Exposure Scenario containing hazard and exposure information combined with data on use and risk management measures. This information needs then to be written into the extended Material Safety Data Sheet in a manner understandable for the DU, in order to ensure safe use.

The answer is yes for transported isolated intermediates from Japan, provided the requirements for rigorous containment can be convincingly documented.

If no chemical reaction takes place, the product is called a formulation. However after a chemical reaction a new substance is created and a registration is needed for the gas.

For both questions the answer is no.

Third party advisors can be used to evaluate dossiers or parts of dossiers. Such an independent opinion may have additional weight for the authorities upon evaluation of a dossier or a test plan. There are no such formal qualifications, and many service providers could in fact act in this role. As a rough uide:proven experience in toxicological and environmental testing in addition to experience in risk assessment in the European context would be basic qualifications.

Third party specialists are essential to the operation of REACH, as many companies do not have specialist capacity sufficient to meet the oncoming workload in house. Third party advisors will in practice work for lead registrants, active members of consortia as well as passive members of SIEFs. This will also apply to Importers and OR’s.

a) There is no standard method for collecting information from DUs on use and usage information.

A few questionnaire formats have also been tested, including form CEFIC. At present, the most likely approach that most registrants will use is to describe the uses based on their in-house knowledge and to ask (branch organizations of) DUs to expand and improve these descriptions. Another potential development is to put such in-house made descriptions on a web-site and to ask clients to correct and add to this information. The ES Modifier (a tool which combines exposure models) can in the future be used for gathering information from DUs.

b) There are several locations where DUs can place their input in IUCLID 5. In any case ‘recipients’ (as DU are) can be added.

If we understand the question correctly, the following answer will hopefully suffice: thetimelines are the same for Manufacturer, Importer and Only Representative (OR). The name of the importer does not have to be disclosed at registration with an OR appointed.

Generally speaking, an SDS is required for a substance when it meets the criteria for classification and labeling. The monomer should be registered in the same way as any substance.

Under the current legislation (Directive 67/548/EEC), a substance should be notified if 10 kg or more will be marketed in the EU. If the substance is notified according to this directive, this notification will also be regarded as a registration under REACH (no action by the notifier is needed, and the substance can remain marketed).

If the substance is not notified according to Directive 68/548/EEC, but if it does appear on the EINECS list, the substance is a so-called phase-in substance which should be pre-registered before December 1, 2008. The substance can remain marketed.

In the above cases, if the tonnage level exceeds 1 tpa, the additional information corresponding to this tonnage threshold has to be submitted.

If the substance is not notified according to Directive 67/548/EEC and also does not appear on the EINECS list, a new registration for tonnage level of >1 tpa, will have to be done. The substance can only be marketed after the registration is complete. The part of REACH governing non-phase in new)substances comes into force at the start of Pre-registration on 1 June, 2008.

The UVCB has to be registered as a whole. However, generally speaking the hazard is often evaluated on the basis of information on the main constituents.

See also RIP 3.10: registration as a UVCB.

If the residual monomer is more than 2% and more than 1t/y in total then it is to be considered for eventual registration.

Substances manufactured, imported or used for the purpose of scientific research and development are exempted from registration obligations. However, the manufacturer or producer must notify the Agency of his intention to carry out PPORD (by himself or in cooperation with listed customers) on a substance.
Therefore, an electronic notification should be provided to the Agency. This notification should contain the following information:

• Identity of the notifier
• Identity of the substance
• Classification and labeling
• Estimated quantity
• Listed costumers

The notification of a PPORD substance has nothing to do with pre-registration.

There has been much discussion on strategies for pre-registration, i.e. the advantages or disadvantages of pre-registering early or late; this is up to the registrant and TNO has no advice on this topic. Much depends on the availability from ECHA of information on SIEF members during the Preregistration period.
Please consult RIP 3.4: guidance on data-sharing (pre-registration) for more information on this subject.

A SIEF can have many companies (potential registrants) as members. The aim is to exchange data, of which some can be business sensitive. For a smooth functioning of the SIEF process a facilitator can be appointed as a third party [we doubt if this will be equivalent to an independent third party] to facilitate communication and to help retain confidentiality of the confidential business information. In practice, the work of important SIEFs will be done by an industry consortium.

Speed in the preparation of a consortium’s contractual arrangements is essential to remain on time for a 2010 registration. In some cases, the technical work will need to begin, possibly with the help of an independent third party, while the consortium arrangements are still being finalized ? we are aware of practical examples of this.

It is not a problem to stop working in a SIEF in a case where the substance will not be registered, or where a company no longer has a commercial interest in a particular substance. However, SIEF and/or consortium contractual arrangements may include obligations with regard to e.g. costs.

For pre-consortia information, please see
http://www.reach-compliance.eu/

For CEFIC sector groups, please see
http://www.cefic.be

There are two situations relevant to this question.

• a company may opt out of joint registration on certain grounds. However, this will lead to a prioritized evaluation of the dossier.
• The DU is responsible for the information on substance use to be included as part of the CSR. The DU is allowed to write the exposure and risk assessment separately (without opting out) when it concerns CBI, or for other reasons.

Not being able to write the CSR on grounds of cost would mean no registration.

The only EASE model known to us is the “Evaluation and Assessment of Substance Exposure”, which is the present model for exposure assessment of workers in the scope of New and Existing Substances assessment. The new Advanced Tool, combines measured data and models via a Bayesian (and probabilistic) technique. This method is under development and will not be available before the end of 2008. It is specifically intended to be applied as part of the risk assessment process in REACH, as a Tier 2 tool. This tool will be useful when Tier 1 tools (ECETOC TRA and Stoffenmanager) are too conservative to show safe use. See also RIP 3.2-2.

a) Exposure, Tier 1 tools
The relevant Tier 1 exposure tools are mentioned in the Technical Guidance Document that has recently been finalized. These include:

• STOFFENMANAGER (for worker exposure, inhalation) designed by TNO and the ArboUnie Netherlands [downloadable from https://www.stoffenmanager.nl/Default.aspx]
• CONSEXPO (for consumer exposure assessment)
• ECETOC TRA (for worker exposure and perhaps also for consumer exposure; an updated version will be made)
• RISKOFDERM (for worker exposure ? dermal - a user friendly version in spreadsheet format will be available in the beginning of next year)

Tier 2 exposure tools
The new Advanced Tool, combines measured data and models via a Bayesian (and probabilistic) technique. This method is under development and will not be available before the end of 2008. It is specifically intended to be applied as part of the risk assessment process in REACH, as a Tier 2 tool. This tool will be useful when Tier 1 tools (ECETOC TRA and Stoffenmanager) are too conservative to show safe use.

Environmental risk assessment EUSES (environmental exposure; both original version and spreadsheet version)

b) General IT support tools The Tier 1 tools above will all be combined in a new tool called “ES Modifier” of which a demo version (EXCEL) should be available in2008.

Another tool that is being developed is a CSR IT tool that can gather relevant information from IUCLID 5 and combine it with exposure model results into a Report in a relatively automated way. This tool should (in the future) include some standardized Exposure Scenarios. A blueprint should be available in the middle of 2008, but it will be at least a year after that before the tool itself will be available.

No specific list is available. However, according to article 57 (f) endocrine disruptors can be included in Annex XIV. See also Q&A 3-2 below.

No specific list is available. However, according to article 57 (f) endocrine disruptors can be included in Annex XIV. See also Q&A 3-2 below.

Answer specifically to Q3-3 and in general to Q3-4

Article 56 (a) and (b) describe exemptions. (a) describes under which circumstances, when a substance has been authorised it is possible to put it on the EU market. A substance incorporated in an article can only be placed on the EU market when authorized (when it is below 0.1% of the composition, this is not necessary). (b) refers to art 58(2) where use exemptions are described.

Given that REACH applies equally to substances manufactured in or imported into the EU, it seems unlikely that a substance incorporated into an article outside the EU would not be subject to the same authorization requirements.

Artikel 33 refers to article 59 (1) and to a candidate list allowing discussions prior to inclusion on Annex XIV. It should be noted that many high volume substances are currently under investigation.

This answer specifically to Q4-1 and in general to Q4-2

This is a question which requires a case-by-case approach in our opinion.
REACH includes many animal tests as part of the standard requirements, depending on the volume band. Such tests should not be conducted if the end point can be addressed by read-across or by applying weight of evidence or any other scientific or technical waiving feature of Annex XI. For the animal tests under Annexes IX and X for higher volumes, a proposal with argumentation for testing should be included in the registration dossier. ECHA will evaluate the proposal and advise on how to proceed. Such animal tests should not be initiated before having received approval by ECHA.

Animal tests to demonstrate the safety of an ingredient for cosmetic use are outside the scope of REACH, because safety in such a case remains under the jurisdiction of the Cosmetics Directive. Animal tests under this Directive will be banned in the EU from 2009. A problem arises when the use of the substance is dual or multiple, i.e. for both REACH and industrial use as well as for cosmetics.

Answer specifically to Q4-2 and in general to Q3-1

The current EU policy does not provide for a difference between tests conducted in or outside the EU. It applies generally; otherwise it would not have any meaning. [We take this to mean that the use of tests conducted outside the EU after the 2009 deadline would not be allowed].

Additives such as light stabilizers etc. do not have to be registered separately. They are considered to be part of the substance in the polymer, and therefore should be part of the registration of the substance.

The EU Directive on food packaging materials is separate from REACH, so such substances are not necessarily exempted , it depends on a number of factors:

• Polymerized monomers >/= 2% wt and above 1 ton and any other substance chemically bound to polymers should be registered.
• Any additives to preserve the stability of the substance are part of the substance and need not be registered unless they are manufactured separately in quantities > 1ton.
• Impurities are part for substance and need not be registered separately.

In the case of imported polymers and master batches, you are obliged to register not only the monomers but also all other substances used such as additives colourants, etc, with the exception of stabilizers as indicated above.

Mono-constituent substance: defined by its composition, in which one main constituent is present to at least 80% (w/w).

Polymer: A substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer compromises the following: (a) a simple weight majority of molecules containing at least three monomer units which are covalent bound to at least one other monomer unit or other reactant; (b) less than a simple weight majority of molecules of the same molecular weight. In the context of this definition a monomer unit? means the reacted form of a monomer substance in a polymer.

Impurities: are part of a substance, and this substance should be registered. Impurities do not have to be registered separately.

If the residual monomer is more than 2% and more than 1t/y in total then it is to be considered for eventual registration. Monomer C exceeds these quantities in the case of Polymer A+B and would therefore need to be registered in our opinion.

Use of the identification tool is meant for EU community exported registered substances, as such or in preparations which are re-imported into the EU. Upon re-import it needs to be proven that the re-imported substances are exactly the same as were exported previously and that the supplied information on the exported substance is according art. 31 and 32.

If an actor of the specific substance in the supply chain (see also definition 3 (17)) re-imports this previously exported registered substance (as such or in preparations), then this actor has the role and obligations of a downstream user.

The responsibility to fulfill the obligations under REACH lies with the importer within the EU. They will have to fulfill registration obligation according to Article 6 or 7. Only in case the where a Japanese company appoints an only representative (OR) according to Article 8 of the regulation will this entity then become responsible.

Amongst a wealth of other detailed information, the Importer/OR will have to be aware of the requirements for extended Material Safety Data Sheets (MSDS) containing appropriate exposure scenarios (ES). In the case of preparations, this may involve several MEDS and ES

Inspection in the EU can vary depending on the Country and point of entry, e.g. Rotterdam or Antwerp. In effect