What are the overall goals of the new chemicals regulation?
The two most important goals are to improve the protection of human health and the environment from the hazards of chemicals and to enhance the competitiveness of the EU chemicals industry. Enterprises that manufacture or import more than one ton of a chemical substance per year will be required to register the chemical in a central database.
How does REACH provide for punishments/penalties/fines/imprisonment? Are they country-specific punishments or EU-wide punishments?
Penalties are country-specific and Member States will impose a penalty for non-compliance which will be effective, proportionate and dissuasive.
How will ECHA monitor REACH implementation?
ECHA will request reports about REACH implementation from member states. The national authorities will perform the implementation checks.
Will each company that registers a substance receive a different registration number for it?
Yes, each company receives an individual registration number.
Are there different requirements to be introduced for Small and Medium Enterprises (SME)?
Small and medium-sized enterprises (SME) are a vital part of the EU chemicals industry; for that reason the Regulation has been made workable also for them (e.g. a lower registration fee). Since safety is a key concern regardless of company size, the REACH information requirements relate to production volumes, uses and properties of the chemicals, and not to turnover or the number of employees of the companies.
SME will face more difficulties in compliance with REACH administration than large-scale enterprises. How did the EC balance the different interests between the large-scale enterprises and SME?
For the most part, SME are more likely than other companies to be registering at the 1-10 t/y level. They will therefore benefit from the longest transition period and a lower registration fee will be required. The information requirements for these volumes are also light compared to the higher tonnages and no CSR needs to be developed.
What are the substances within articles that have to be registered?
Pursuant to Article 7(1) all substances in imported articles that meet the following two conditions must be registered under REACH: 1. the substance is present in the imported articles in quantities above 1 ton per importer per year, and 2. the substance is intended to be released under normal or reasonably foreseeable conditions of use.
Which substances are exempt from registration?
Some substances are exempted from REACH altogether and so will not be subject to Registration, for example: radioactive substances, non-isolated intermediates, wastes, substances under customs supervision, and, if Member States so choose, substances necessary for the interests of defense. In the REACH regulation you will find a more comprehensive list of general exemptions within Article 2 and Annex V and more specific substance exemptions within Annex IV. Substances manufactured or imported in quantities less than 1 ton per year do not need to be registered.
Is there an obligation to register steel or other alloys?
Alloys (including steel) are Preparations under REACH, albeit special ones where the properties of the Preparation do not always simply match the properties of the components. As Preparations, alloys do not have to be registered but their component metals must be registered if manufactured/imported in quantities greater than 1 ton per year.
When is windscreen washer fluid considered a "preparation in a container" and when is it a "preparation within an article"?
When you import a car with windscreen washer fluid in it, then the fluid is a "preparation within an article, which is intended to be released". When you import a barrel/bottle etc with windscreen washer fluid, it is a "preparation in a container." In both cases, the substances within the windscreen washer fluid have to be registered for that use.
Can the industry predict which substances may be subject to an authorization? Are the criteria clear enough?
The identification of the different groups of substances that may be subjected to authorization is clearly defined. For CMR category 1 and 2 substances, the criteria have long been established in the present legislation (Directive 67/548), for PBT and vPvB substances the criteria are included in REACH Annex XIII. For any other substance there must be scientific evidence of probable serious effects to humans or the environment, which give rise to an equivalent level of concern as CMRs category 1 and 2, PBTs or vPvBs. To provide more certainty for industry, substances will be identified through an open process and the decision to include the substance in REACH Annex XIV will finally be taken by the Commission in accordance with the Comitology procedure. The process for such decisions is as follows: Dossiers to identify a substance for the authorization procedure will be prepared either by a Member State or by the Agency if requested by the Commission. All dossiers will be published and will be open for comments by interested parties. Substances identified as having any of the listed properties of very high concern will be included on a candidate list published by the Agency, within which the Agency indicates the substances that are on its work program. The Agency then recommends substances to the Commission for inclusion in REACH Annex XIV. Priority will normally be given to substances with PBT or vPvB properties, with wide dispersive use or in high volumes. These priority substances may then finally be included in REACH Annex XIV.
Can applications for authorization be submitted together?
Grouping of applications for authorization is possible in REACH. Groups can be of: manufacturers, importers and DUs; substances; uses; or any combination of these groups. This is to enable costs to be minimized and the system to process applications rapidly.
Which are the substances within articles that require agency notification?
Pursuant to Article 7(2), SVHC listed on the candidate list for Annex XIV that meet the following two conditions must be notified under REACH: 1. the substance is present in the imported articles in quantities above 1 ton per importer per year, and 2. the substance is present in the imported quantities above a concentration 0.1 % weight by weight.
How will notification work for DUs of substances under the product & process oriented research and development (PPORD) exemption?
The PPORD exemption from registration (Article 9) is for manufacturers and importers doing research, either by themselves or with listed customers. The substances for these uses do not require registration (and DU requirements do not apply because the supplier is not required to prepare a Chemical Safety Report) and would not be supplied to others in the supply chain for commercial purposes or to the general public at any time. However if the substance is used in quantities greater than 1 ton per use per year, the DU must notify the Agency.
If a product contains more than 0.1% weight by weight (w/w) of SVHC, a manufacturer is liable to submit notification. Should 0.1% be calculated in terms of vehicle weight or component weight?
Always use the weight of the article manufactured in or imported into EU.
How is chemical control in REACH linked to waste control?
For all substances above 10 tons / year, a Chemical Safety Report (CSR) and a Chemical Safety Assessment (CSA) assessment have to be prepared. This risk assessment has to take into account all ways (including waste streams) in which the substance could contaminate the environment. "Waste" by it self is exempt from REACH and need not be registered.
We understand that REACH assumes that the European Chemicals Agency is responsible for the registration and assessment of chemicals. In which organizations are mechanisms for conveying information on substances contained in articles discussed?
The ECHA is the only agency registering substances. The agency will deliver IT tools for all registration and notification obligations.
Is there a mechanism for conveying information on "use" to upstream suppliers? Shouldn't automobile industries in different countries share the recognition of "use?"
Communication within the supply chain is key for REACH compliance. The Automotive Industry, along with others, is building up networks. TF-REACH is an important part of this.
Approximately how many substances are treated as SVHC?
The candidate list will be established toward the end of 2008; a rough estimate is 1000-2000 substances. From 2011 the REACH Annex XIV priority list will be updated at least every 2 years.
Will all SVHC substances be disclosed at one time?
Priority list for inclusion of the substances within REACH Annex XIV will be established and published for comments, so not all will be included at one time. It will be an ongoing process for years to come.
If chemical constituents of materials for automobiles must be registered, upstream resin manufacturers should be requested to respond to the requirement. Does the TF-REACH request resin manufacturers to register those chemicals?
Roles and responsibilities are described under REACH. It is the task of the individual companies to make their suppliers aware, see this Guideline.
How about parts purchased from outside the EU? How will you direct the suppliers to respond to REACH?
The obligations for importers are described in REACH and this AIG.
Shouldn't automobile industries in different countries share the recognition of exposure scenarios of substances "intended to be released?"
We share our experiences within the TF REACH.
What are the obligations of a distributor?
A distributor has the obligation "not to interrupt" the information flow within the supply chain. He has to pass the information needed for REACH compliance up and down the supply chain. (REACH article 34).
If IMDS is used for REACH, how is information on "use (purpose of use)" conveyed from DUs to upstream suppliers to meet the requirements of REACH?
IMDS could only be used for articles going into products. Further uses are currently not possible.
How can we set up a system for implementing REACH with respect to process materials (raw/auxiliary material) in our EU manufacturing facilities?
If you follow Health, Safety, and Environmental legal requirements in Europe in your facility you will have enough information about your process materials and can make sure your suppliers/importers are aware of REACH. Therefore we recommend using the pre-existing tools in your company.
Is it necessary to inform your supplier if you are a DU and using a substance at less than 1 ton per year?
Yes, because your supplier must note your usage on the SDS regardless of the tonnage.
What are the responsibilities of a non-EU company who has nominated an Only Representative?
Non-EU companies have no obligation under REACH. Compliance with REACH must be ensured by their EU-based importers (i.e. they have to register the substance, provide safety data sheets where necessary, etc.). In order to allow importers to fulfill their obligations, non-EU companies will however have to provide the necessary information on the substance to the importer. If a non-EU company does not wish the importer to be responsible for obligations under REACH (e.g. if the non-EU company does not wish to disclose confidential information), it may appoint an Only Representative. In this case, the Only Representative takes over all obligations of the importers under REACH. (See also ECHA website and article 8 of REACH regulation).
Are EFTA member states included in the scope of REACH?
Iceland, Liechtenstein, Norway and Switzerland are members of the European Free Trade Agreement (EFTA). The EFTA Convention established a free trade area among its Member States in 1960. Iceland, Liechtenstein and Norway entered into the Agreement on the European Economic Area (EEA) in 1992, which entered into force in 1994. Therefore, the EEA is composed of Iceland, Liechtenstein, Norway and the 27 EU Member States. As soon as REACH is implemented by the EEA EFTA-States (which means EFTA States covered by EEA agreement), imports from Norway, Iceland and Liechtenstein will be considered as intra-Community trade for the purposes of REACH. EFTA is preparing a proposal for an EEA Joint Committee Decision, incorporating the Regulation and establishing the conditions for the EEA EFTA participation in the EU Chemicals Agency. EFTA is targeting to have the Regulation incorporated by 1 June 2008. Therefore, an importer of a substance from an EEA country would not be required to register the substance under REACH and would simply be regarded as a DU. However, his supplier in the EEA/EFTA States will have to register the substance as a manufacturer under REACH with all associated obligations like any other manufacturer within the EU. Importers of a substance from Switzerland (a non EU country belonging to EFTA but not to EEA) will have the same obligations under REACH as any other importer. Examples: A formulator purchasing his substances in Germany or Iceland will be considered as a DU. A formulator purchasing his substances in Switzerland or Japan will be considered as an Importer.
When will Norway, Iceland and Liechtenstein bring REACH into force?
June 1, 2008 is the estimated date.
Does the candidate list exist already?
No, not yet. This list has not yet been established. The Agency will publish and update this list on its website once it is available, near or after late 2008. The Agency shall make its first recommendation of priority substances selected from the candidate list to be included in Annex XIV by 1 June 2009. This list will be made available on the ECHA website. You can find more information on this issue in the Guidance on identification of SVHC and in the Guidance on Annex XIV inclusion on the ECHA website.
What about non-automotive products like machinery or tools which are exported into the EU?
The exporter has no obligation. Under REACH, the importer within the EU is responsible to fulfill all requirements. The exporter has to deliver the information about SVHC. If this is not possible, the importer can ask the exporter to announce an "Only Representative" who will take over all duties under REACH.
How will the new legislation ensure confidentiality of information with a public list of chemical substances?
The first list of substances that the Agency publishes will be the list of pre-registered substances. This list will be comprised of only the names of the substances and not the names of any company manufacturing or importing it. The purpose of this list is to give an overview of the substances that will be phased into REACH.
Is a waste treatment operator a DU under REACH?
The treatment of waste material itself is not a use of a substance or preparation and, therefore, the operator is not a DU under REACH.
What information network has been built for supply chains in Europe?
It is responsibility of the Industry to determine how to handle this.
Is there a legal requirement to pre-register all substances?
There is no legal obligation for it, but pre-registration is strongly encouraged to gain the benefit of the extended registration deadlines.
What happens if we, as a DU, find out after pre-registration has ended that our substance has not been pre-registered?
You can ask the ECHA to publish your name and substance on its website, which will enable potential registrants to contact you (REACH Article 28.5). The new potential supplier can pre-register it by sending the information described in REACH Article 28.1 within 6 months of first manufacture/import or use (REACH Article 28.6). Also, this information must be sent at least 12 months before the phase-in deadline. If the supplier is not manufacturing/importing it for the first time, they cannot benefit from the phase-in dates and must register it immediately in order to continue supplying it.
Is it right to think that the mechanism for registration and restriction of new chemicals is almost the same as the existing one?
Yes, substances put on the market after 1981 and compliant with the existing regime are seen as "REACH compliant".
What substances should OEMs register?
Each OEM must identify its role under REACH. If the company imports substances or substances in preparations then they have to register.
What kind of SVHC do we need to take care of?
See Guideline 8.
Considering that supply chains spread beyond national boundaries, the implementation of REACH requires the cooperation of different countries. Does the EU have a plan to promote activities to raise awareness of REACH?
Each Member State has to establish "National help desks, these help desks will network together. Raising awareness is a task for industry and its associations. The responsibility for complying with REACH lies with the industry.
What does it cost to use the Reach-IT system (including IUCLID5)?
IUCLID 5 can be downloaded free of charge from the ECHA homepage, see Guideline 12.
If a supply chain extends into more than one country, it may be difficult to collect sufficient information on the content of SVHC.
In light of this difficulty, sufficient time should be allowed for data collection. Start collecting the information you need now.
We think that preparations "intended to be released" include brake pads (preparation) and windscreen washer fluid (preparation) in RIP 3.8. What is the TF-REACH opinion about this point?
This AIG makes it clear. We and the brake pad supplier organizations have the same opinion: brake pads are articles with no "intended releases". The guideline includes the intended AI releases, see Chapter 5.7: Guideline 7 and RIP 3.8.
After the raw materials to be used in paints, rubber, adhesives, etc. are shipped by the chemical industry, suppliers might add more substances. How strictly should OEMs control these materials?
In general, all substances have to be registered, independent of when or who has added it to a product.
Is there a plan to ask suppliers to pre-register their substances/preparations? If so, could you please tell us the expected period of pre-registration?
The pre registration period is 1st of June 2008-1st of December 2008. Proposals for an awareness letter and a declaration of intent are in this guide.
Does TF-REACH consider using IMDS as a method for collecting information on SVHC contained in articles for REACH? Or does the TF-REACH have a plan to build another tool?
For companies already working with IMDS or other substance reporting systems, it makes sense to use those tools. The prerequisite would be an updated restricted-substance list (e.g. GADSL).
Does TF-REACH think that SVHC should be controlled or that the GADSL can be used?
TF REACH addressed this to GADSL team members. GADSL should cover SVHC in the future.
Does this guideline cover the standard REACH implementation process for OEMs?
This is a recommendation for a standard REACH implementation process, but how the process will specifically work at the OEMs depends on so many Company specific factors that an honest answer cannot be given.
What are "Appropriate Instructions" and how are they to be provided? Is it possible to include the information in the pre-existing systems?
Yes, but other solutions are possible as well.
What about packaging material included with the articles from outside EU?
If the packaging material becomes "waste" within the EU (not put on the market) it is exempted from REACH.
In the AIG it is stated that "substances listed in ELINCS are regarded as registered" per Article 24. Clearly, registration is not required from the person who notified the substance under Directive 67/548/EEC. Must others who use the ELINCS substance register it, or is it regarded as registered for them also?
ELINCS substances are regarded as registered only for companies who submitted the required information under Directive 67/548/EEC. The Agency will assign a registration number by 1 December 2008 Source: Article 24(2) says "if the quantity of a notified substance.reaches the next tonnage threshold.additional required information.shall be submitted." The concept of next tonnage threshold is only meaningful for those who submitted information for a particular tonnage threshold under Directive 67/548/EEC.
One of the registration requirements is "(a) the substance is present in those articles, in quantities totalling over 1 tonne per producer or importer per year." We understand that this 1 tonne is for each individual producer or importer. Is our understanding correct?
Yes, it is per producer or importer (legal entity).
Could you be more specific about the expression "the substance is present in those articles above a concentration of 0.1% weight by weight?" Because a general automobile weights about 1,500 kg, 0.1 wt% of an automobile is 1.5 kg. It follows that substances used in an automobile should be controlled if the weight exceeds 1.5 kg. Is this understanding correct?
Yes, if a car is imported (the article in this case), this is correct for SVHC.
Manufacturers of final products are required to confirm that the use of SVHC contained in Articles (such as materials, parts, and subassemblies) has been authorized for a certain purpose. Suppose that substance X is a SVHC. (Case 1) When a final product contains 2% (w/w) of substance X:
The article manufacturer/importer notifies the agency.
Manufacturers of final products are required to confirm that the use of SVHC contained in Articles (such as materials, parts, and subassemblies) has been authorized for a certain purpose. Suppose that substance X is a SVHC. (Case 2) When a final product contains 0.05% (w/w) of SVHC substance X:
0.1% (w/w) is the threshold. If X is below 0.1% this obligation does not apply.
We understand that chemical manufacturers are basically responsible for the registration of new and existing chemical compounds, and automobile manufacturers need only be concerned with preparations "intended to be released." What does the TF-REACH think about this point?
You must identify your roles and responsibilities under REACH. Use the AIG and / or consult the REACH Navigator under: http://reach.jrc.it/navigator_en.htm
What do you think about legal compliance with REACH? Of course automobile manufacturers should respond in good faith. However, how do you check the contents of SVHC contained in articles that are difficult to check by data or by other means?
"Legal Compliance" is a need for each company in the supply chain. Your supplier has to inform you about SVHC in the products he delivers to you. You are obliged to deliver information about SVHC to your customer after you have received it from your supplier. There is no obligation for you to make chemical analyses if you have no information about non-compliance of your supplier.
Most primary suppliers (Tier 1) are the only users of chemicals, and do not have complete information about the constituents of materials they deal in. There is a high probability that the requirements of REACH cannot be satisfied through cooperation with primary suppliers alone. What does the TF-REACH think about this point?
Communication must go through the whole supply chain, not just Tier1.
The "use" is the key to REACH. Some metals may serve as a catalysts when reduced to a fine powder but do not have oxidizing properties when used for decoration or plating. In this case, is it right to think that the metal must be registered as a "catalyst?"
The substance must be registered for the appropriate "Use and Exposure Category" depending if it is used as a catalyst or alternatively for decoration or plating. RIPs will clarify this.