2
FAQ: REGISTRATION
2.1
What to register
2.1.1
How many substances have to be registered?
2.1.2
As stated in the proposed regulation, about 30.000 chemicals in more than 100.000 existing chemicals should be registered, could you offer us the list of these chemicals?
2.1.3
Which substances have been exempted from registration?
2.1.4
EU-regulation on existing substances has as Annex II a list of exemptions in the regulation - substances like glucose etc. Annex IV of the proposed REACH regulation is the same list of exemptions. Can you explain what the criteria behind the list were?
2.1.5
As we understand, chemicals shall be registered according to its manufactured or imported volume, but how do you calculate the volume of a chemical in a downstream product, especially for those downstream products not originally made of chemicals?
2.1.6
How would a manufacturer register a preparation containing many kinds of chemicals?
2.1.7
Are there more detailed rules for the registration for downstream uses such as finished plastics, textiles and toys?
2.1.8
Shall the importer of a preparation register only those substances defined by dangerous preparation directive (1999/45/EC) and SDS directive (91/11 5/EC)?
2.1.9
When taking into account that in a manufacturing plant, rubber (=polymer, elastomer) is mixed together with additives (a number of preparations) to obtain a blend. If we produce this blend in a factory A where it is partly further processed into an article and the other part is transported to another factory B. Will it then be required to register this blend and is there any difference whether or not this factory B is of the same company or not? What information has to be used for the chemical safety assessment in the case a registration is required (individual substances, individual preparations, blend)?
2.1.10
How can the importer of a preparation be guaranteed that all substances to be registered are declared and therefore known to him?
2.1.11
A clear product group registration option is needed - currently hundred of our products are "chemically similar", but commercially different ones. Few defined product groups by the industry and based e.g. on applications would solve the problem and save resources.
2.1.12
Is there an obligation to register steel or other alloys?
2.1.13
Are fluid glass mass and solid glass products substances, preparations or articles under the REACH?
2.1.14
Is there an obligation to register metals?
2.1.15
How will substance X be treated under REACH?
2.2
Who may act as a registrant
2.2.1
Who can register a substance (on its own or in a preparation)?
2.2.2
What is the process for a "pan - European" registering instead of a national one - we are producing under same product names in many EC countries? Would it be cheaper to register European wide - any limitations to do it?
2.2.3
What benefits could the companies get from forming consortia?
2.2.4
Could companies use consortia to exclude new entrants from registration?
2.2.5
Is it possible for a non-EU enterprise to register jointly with an EU enterprise?
2.2.6
Is it possible for industrial associations not located in the EU to register collectively on behalf of a specific industry?
2.2.7
Basic chemicals will be registered by European producers. Why should well known international chemicals be registered still by an importer - of course some kind of announcement on volume etc. is needed?
2.2.8
When importing the same product from different manufacturers in different third countries, is it necessary for the EU importer to conduct repetitive registrations for the different manufacturers? And who does the related property right belong to?
2.2.9
For a group company and its branches, and for a holding company, is it possible to share the registration property right and pay one registration fee?
2.2.10
May non EU manufacturers of preparations or articles appoint an ‘only representative’?
2.2.11
What is the difference between the role of conventional ‘sole representative’ and ‘only representative’ in art 8?
2.2.12
Why should non EU manufactures use an ‘only representative’?
2.2.13
Does Art 8 empower the ‘only representative’ to carry out the non-EU manufacturer's obligations?
2.2.14
Will non-EU manufacturers of chemicals through their representative be subject to all the obligations imposed on importers under the REACH?
2.2.15
Does it mean that the representative "substitutes" the manufacturer?
2.2.16
Article 8(3) stipulates that the exporter should inform “importers in the same supply chain” of the appointment of an only representative. What is the meaning of those words?
2.3
Information requirements
2.3.1
Is a new registration required each time the degree of purity is changed (that is substance quality is improved)? Wouldn’t that hamper innovation?
2.3.2
If there were 20 producers and importers manufacturing or importing the same chemical substance at the level of 50 tons per year, should those registrants submit information required under Annex X?
2.3.3
Do article 11 and Title III apply to producers and importers of articles?
2.3.4
Importers may not have information on the substances in the preparations or articles they are about to import into the EU.
2.3.5
Can a chemical manufacturer refuse to register a particular use communicated by the user (“identified use”)?
2.4
Chemical Safety Assessment / Chemical Safety Report
2.4.1
A non phase in substance (~10t/yr) would require a manufacturer or importer to have a CSR in place 60 days after entry into force. Please confirm this is correct.
2.4.2
For a phase in substance a CSR is required when the substance registration is required for a 10-100-1000 tonnes/annum substance. Please confirm this is correct.
2.4.3
For all substances/preparations (phase in and non phase in) the enhanced SDS is required, if relevant, 20 days after entry into force. Please confirm this is correct.
2.4.4
Substance versus preparation. According to the CSA/CSR/exposure scenario requirements, there is no obligation to assess preparations. Only substance assessments are required.
A formulator of a preparation (e.g. as a downstream user) has to develop exposure scenarios (for substances manufactured/imported at or above 10 tonnes/year) for uses not covered by the SDSs. He will have been supplied by his M/I with SDS for the (different) substances. How does he prepare an SDS for the preparation that he will supply to his DU? NB: When REACH enters into force, the Safety Data Sheet for a preparation should describe safe use of the preparation – just as today? In other words, the CSR/exposure scenario requirements seem to clash with the SDS requirements for preparations.
Similarly, the substance-bysubstance assessment does not comply with Dir. 98/24, requiring that chemicals (substances and preparations) can be used safely. What should the formulator do? The formulator that forwards the preparation needs to assess the his supplier(s) of the substances or if the relevant substance was preparation?
2.4.5
According to Article 14, a full CSA shall be conducted for substances manufactured in a volume > 10 tpa, if it meets the criteria for C&L. According to annexes IX & X, some of the ecotoxicity tests may be waived, if direct or indirect exposure is unlikely. This pertains to e.g. bioconcentration, effects on terrestrial organisms (short and long-term), effects on birds.
Assuming that it will not be possible to document that exposure is unlikely without conducting an exposure assessment and an exposure assessment is only required for hazardous substances (meeting the C&L criteria), but not for nonhazardous substances. Does this mean that these tests are then always required for non-hazardous substances, while they may be waived for hazardous substances? One could assume that implicitly such tests are not required, but it is not stated anywhere that the data requirements should be interpreted in this way.
2.4.6
What is the difference between CSR and SDS?
2.4.7
Should not all the information in the CSR go down the supply chain?
2.4.8
What about criticism that SDSs are ineffective today?
2.4.9
Concerns related to proprietary of information submitted during the registration phase of a substance. Exposure Scenarios have to be annexed to SDSs and, hence, made public.
2.5
Prioritisation of registration
2.5.1
Which laboratories or institutions in which countries could be recognized or designated to supply their testing data or information? Is the European Commission going to develop a detailed list of recognized or designated laboratories of institutions?
2.5.2
Why is there not more prioritization?
2.6
Mutual recognition on testing results
2.6.1
Which laboratories or institutions in which countries could be recognized or designated to supply their testing data or information? Is the European Commission going to develop a detailed list of recognized or designated laboratories of institutions?
2.6.2
Under the REACH regimes, it is stipulated that existing toxicity and bio-toxicity information and epidemiological evaluation results should be fully taken into account. What information is acceptable?
2.7
Completeness check
2.7.1
How does the Commission see the completeness check carried out?
2.8
Fees
2.8.1
How will the fees be shared when products are imported to EU through a trading partner in a third country?
2.8.2
For a registered chemical, any following registrant should pay for sharing the initial registration fee, we wonder what’s the proportion for them and as for separate downstream users how do they pay for the share of initial registration fee? As for one use of one chemical, there may be hundreds, thousands downstream users or even more, if each of them should pay half of the initial registration fee, it is obviously unreasonable and the Chemical Agency and the first registrant will make a lot of profit from it.
2.9
Articles
2.9.1
How are the requirements for substances in articles related to the existing requirements under Dir 67/548/EEC on the notification of new substances in articles?
2.10
Polymers
2.10.1
How are polymers covered by REACH?
2.10.2
What is the difference between:
67/548/EEC (Art. 13(2)): polymers, with exception of those which contain in combined form 2 % or more of any substance which is not on EINECS;
REACH: The polymers consists of 2% weight by weight or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance/s);
2.10.3
What should be registered in practice - monomer or/and polymer?
2.10.4
Who would be responsible for registration of monomers - polymer producer vs. chemical supplier?
2.10.5
For non-registered monomers the registrant is not specified by an actor up the supply chain. Does this mean that any monomer already registered by someone is exempted from the registration obligation?
2.10.6
Does the term “consists of” mean a monomer “used” for more than 2% in the production of the polymer or a monomer “contained” in the polymer over 2% as a monomer unit?
2.10.7
The plastic industry to a large extent imports plastic granulates. The only processing is that they melt it and form the final product. The granulates consist of polymer(s) and various additives, colorants, etc. Should these granulates be considered as polymers, preparations, or something else?
2.10.8
Requiring the importer of polymers to register non-registered monomers that were reacted offshores
- puts the importer at a knowledge disadvantage: details on monomer identities and their percentages are often confidential and not available for importers
- jeopardizes non-European exporters’ intellectual property
- creates a disincentive to import polymers
2.11
Intermediates
2.11.1
How are the non-isolated intermediates covered?
2.11.2
How are the on-site isolated intermediates covered?
2.11.3
How are the transported isolated intermediates covered?
2.11.4
Does the authorisation system cover different intermediates?
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