REACh Pre-Registration - EU Commission advice - BIR Düsseldorf Convention International Environment Council

REACh –Pre-registration of recovered metals – answer received by the European Chemicals Agency
BIR Düsseldorf Convention International Environment Council Thursday 30th October
REACh Pre-Registration - EU Commission advice
Different motivations for Pre-Registering

REACh -- Pre-registration of recovered metals -- answer received by the European Chemicals Agency

Please note that the commission published a draft guidance on its website. http://ec.europa.eu/enterprise/reach/reach_more_info_en.htm. The version published on the Commission's websites is not a final guidance and still subject to further comments and revision. The draft guidance was handed over to the European Chemicals Agency for further development in cooperation with Member States and relevant stakeholders. The final guidance will be published on the ECHA website once the related consultation processes have been finalised.

According to the document all forms of recovery resulting in substances as such, in preparations or articles (means not treated under waste legislation anymore) are considered manufacture under REACH (see Section 3.1.1.). An example of recovered metals is presented in section 3.1.5.1. As long as the metal scrap however is handled/processed/transported as waste (under the requirements of waste legislation) the REACH requirements do not apply.

We advise you at this point of discussion to pre-register, as only pre-registration will provide legal security that manufacturing, placing on the market, and using the substance can continue until the relevant registration deadline. Please note that "preparations" cannot be registered under REACH and thus the pre-registration of recovered metals should refer to the main, single metal-substance or the main metal-constituents in the scrap with indicating the nature (and range) of impurities. A later registration of the recovered metal-substances will only be required if they are not covered by the registration of the primary metals (including nature and range of impurities, Article 2(7)(d) of REACH).

For new enquiries please use the web form available at: http://echa.europa.eu/about/contact-form_en.asp, being careful to select the most appropriate subject option. For new enquiries related specifically to advice on REACH, proceed via Enquiry on REACH.

BIR Düsseldorf Convention International Environment Council Thursday 30th October

The BIR Düsseldorf Convention - International Environment Council held on Thursday 30th October heard the presentation by Dr Otto Linher, Head of Sector, Unit G.1 REACH, DG Enterprise and Industry, European Commission. [see it HERE]

This was followed by a series of pre-prepared Questions compiled from BIR member companies and association enquiries [see it HERE]. Then Mr. Kees Wielenga of Ffact Management Consultants explained 'what to do next' [see it HERE]. On the Friday of the Convention he made another presentation to the BIR Plastics and Tyres Committee [see HERE].

REACh Pre-Registration - EU Commission advice

The European Commission reiterated in a letter sent out 6th October that there is a "need to pre-register recovered substances that have ceased to be waste".

This advice is in respect of the EU Regulation REACh and substances that are manufactured in the EU or imported into the EU that have "ceased to be waste". The deadline for Pre-Registration is by 1 December 2008.

Different motivations for Pre-Registering

The legal motivation

REACH, the new EU chemicals regulation, requires that chemical substances on their own, in preparations and those which are intentionally released from articles have to be registered to the European Chemicals Agency (ECHA). The regulation applies to substances manufactured in, or imported to the EU in annual quantities of 1 tonne or more per company, unless the regulation indicates otherwise.

The obligation for a company to register applies from 1 June 2008. The chemicals currently on the EU market which meet the definition of phase-in substances should be pre-registered between 1 June and 1 December 2008. Companies who pre-register their substances can benefit from extended registration deadlines. The deadline depends on the tonnage band and the hazardous properties of the substance.

The REACh Regulation Art.2(7)(d) provides relief for Recyclers by exempting from registration recovered substances that have been registered before. But there is no certainty that registrations would have already been made by the end of the pre-registration phase 1 December 2008, so it is unlikely the conditions of Article 2(7)(d) will be fulfilled by 1 December 2008, so final recovery installations should Pre-Register their manufactured substances in order to covers their activities during the period up until the substance(s) is (are) Registered.

The Commercial consideration

Companies that regard themselves as Recovery and Recycling Companies, but that under their national laws have waste as an infeed and waste as an output, in other words companies that are not at the end of the recycling chain as final recovery companies, should not need to Pre-Register or Register those wastes as the REACh Regulation Art.2(2) explains that waste is not a substance, preparation or article in the Regulation Definitions.

However Recovery and Recycling Companies will make their own judgement whether despite not having a legal obligation to Pre-Register there is a benefit to Pre-Registering. Pre-registration gives the chance to communicate with other manufacturers of the same substance in a 'SIEF' Forum. This gives recovery installations access to the contacts to other manufacturers of the substance and, if they wish so, a possibility to contribute to the 'SIEF' Forum discussions. Pre-registration will also allow recovery installations to participate in the discussion on the sameness of substances. Moreover, the 'SIEF' Forum may also be an opportunity to discuss access to safety information, which recovery installations may need to benefit from the registration exemption but also for other obligations they may have under REACh.

Assuming in all EU Member States that the materials that enter Recovery and Recycling facilities are in law waste, then Recovery and Recycling companies should determine the legal position, whether the materials or substances that exit their premises are waste or product under their national law first, then under EU law.

[Indicators that a material exiting an EU Recovery facility is a waste and so not to be pre-Registered in REACh are inter alia: Transporter having a waste carriers licence; A waste placard on the truck; Waste transfer notes accompanying the material; Annex VII forms of the Waste Shipment Regulation accompanying the material etc.]

It has long been the understanding of industry that substances that have ceased to be waste come out of the Waste Legislation and come under REACh Regulation. So BIR representation has focussed on avoiding that both Waste and REACh laws apply to the same substances at the same time, that should be the case though regulators have been somewhat evasive in putting that so plainly in writing.

European Commission helps Recyclers

The European Commission has been very helpful in producing a document that goes a long way to clarifying the interface between Waste and REACh laws.

The letter refers to section 3.2 of the European Commission document CA/24/2008 rev.1 in respect of which the European Commission also compiled a list of answers to questions from stakeholders, including BIR, in CA/24/2008 rev.1 Annex.

Unfortunately EU-27 Member States did not fully agree this document at their meeting at the end of September. The result of such a disagreement is that companies and national associations are advised to ensure they comply with their national laws first as their own government will enforce the Regulation.

On 29th Oct 08 the European Commission revised its document on Waste and Recovered substances, see here the latest document CA/24/2008 rev.2 on REACh Waste and Recovered substances.

Pre-registration is free and simple

Each company needs to make its own decision whether it is legally obliged to Pre-Register or whether there is a commercial or other advantage to do so. If the company decision is to Pre-Register, Pre-registration requires only limited data and there is no fee associated to it.

A pre-registration file for a substance consists of:

Substance Identity: EINECS number, CAS numbers and names of the substance

e.g. for the substance name "Copper" the EINECS number, EC# is 231-159-6;
the CAS# is 7440-50-8 [Search EINECS and CAS# on the website http://ecb.jrc.ec.europa.eu/esis/]
envisaged deadline and tonnage band for the registration

(Manufacturing or import tonnages bands are: > 1 tonne per year; 100 to 1000 tpy; >1000 tpy. For which different registration deadlines apply as: 1st December 2010; 1st June 2013; 1st June 2018.)
name and contact information of a Contact person or Third party Representative who will act as the contact point in data sharing

On-line pre-registration entails, in its simplest form, entering the required information directly into the REACH-IT system.

The European Chemicals Agency (ECHA) provides the following training material here on how to submit pre-registrations on different type of substances via the REACH-IT portal

Anyone that has experience filling in an online form, for example ordering an airline E-ticket, could fill in the Pre-Registration as easily. However be aware of the European Chemicals Agency advice on Pre-Registration and remember the deadline by 1 December 2008.

BIR Düsseldorf Convention Audio-visual Presentations

10 Minute briefing for Traders

In consideration of the REACh Regulation handling of traders established in the EU and those based outside the EU doing business into the EU, this briefing begins with extracts from the ECHA REACh FAQ http://echa.europa.eu/doc/reach/reach_faq.pdf ......

6 Registration

6.1 Who has to register substances?

Only a natural or legal person established within the Community can be a registrant. Registration must take place when this person:

(1) manufactures a substance within the Community,

(2) is responsible for import into the Community or

(3) has been appointed as an only representative according to Article 8 of the REACH Regulation.

The national law of each EU Member State provides the specific provisions concerning natural or legal personality and when such a natural or legal person is established in its territory.

It is very important that companies correctly identify their role (or roles) in the supply chain for each substance they handle, because this will be a decisive factor in determining their registration obligations. More information on roles as a potential registrant can be found in Article 3 (7) to (11) of the REACH Regulation, in the Guidance on Registration (Section 1.5 ¿ Who has to register) or when using the Navigator.

Please note that non-Community companies that are not established within the Community do not have direct obligations under REACH. It is the importer established within the Community that needs to comply with the obligations of REACH. However, to relieve the importers of their obligations, the company not established within the Community may decide to appoint an ¿only representative¿ (see FAQs 4).

6.8 Can a Non-Community manufacturer of a substance register

under REACH?

No. The obligation to register a substance applies only to actors established in the EU. Thus, the registration of substances imported into the EU on their own, in preparations or, in certain cases, in articles will have to be done by the importer established in the EU. This implies that each individual importer needs to register the substance. However, according to Article 8 (1) of the REACH Regulation manufacturers of substances, formulators of preparations or producers of articles established outside the EU, can nominate an Only Representative (OR) established within the EU to carry out the required registration. This will relieve the individual EU importers within the supply chain of that non Community manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this Only Representative. However, the registration obligation may still apply if the EUimporters import the same substance from other non ¿ Community manufacturers.

More information on the Only Representative role can be found in Chapter 4 of this FAQ document and in the Guidance on Registration in Section 1.5.3.4 p. 21.

3.1 To which territories does REACH apply?

REACH is an European Community Regulation that directly applies in all Member States of the European Union. As REACH is of EEA (European Economic Area) relevance, Iceland, Liechtenstein and Norway will apply REACH after it has been incorporated into the agreement of European Economic Area. Substances imported in the Community from Switzerland (a non EU country belonging to EFTA (European Free Trade Association) but not to EEA) are treated under REACH in the same way as substances imported from any other non-EU country.

Member States are best placed to explain how REACH applies to their territories (autonomic areas or overseas territories). We therefore recommend contact with the national helpdesk of the relevant country to clarify specific requirements.

3.2 What are the obligations of non-EU companies?

Non-Community manufacturers do not have direct obligations under the REACH Regulation. It is the importer established within the Community, who needs to comply with the REACH obligations.

According to Article 3 (9) of the REACH Regulation, a manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community. Non EU companies exporting substances on their own, in preparations or in articles to the Community may (but are not obliged to) appoint an ¿only representative¿ according to Article 8 of the REACH Regulation to fulfil the obligations of importers. More guidance on only representatives can be found in the Guidance on Registration (Section 1.5.3.4 ¿ Only representatives of ¿non- Community manufacturer¿) or see also FAQ 4 for details.

4 Only Representative of ¿non-Community

manufacturer¿

4.1 Who can appoint an only representative?

According to Article 8 (1) of the REACH Regulation, a legal or natural person that manufactures a substances (to be used on its own, in preparations and/or to produce articles), formulates preparations or, if the substances in their articles are required to be registered, produces articles, outside of the EU can nominate an only representative located within the EU to carry out the required registration of their substances that are imported into the Community. The only representative will have to fulfil the registration obligations of importers (Title II of REACH) and comply with all other obligations of importers under the REACH Regulation.

More information on the only representative is provided in the Guidance on Registration (Section 1.5.3.4 ¿ Only representatives of ¿non-Community manufacturer¿).

4.2 Who can be appointed as an only representative?

A non-EU company (that can appoint an only representative, see FAQ 4.1) may, by mutual agreement, appoint a natural or legal person established in the European Community to act as his only representative. According to Article 8 (2) of the REACH Regulation this representative shall comply with all obligations of importers under the REACH Regulation. Therefore the only representative is required to have sufficient background in the practical handling of substances and the information related to them. More information on the only representative is also provided in the Guidance on Registration (Section 1.5.3.4 ¿ Only representatives of ¿non-Community manufacturer¿).

4.4 Is there a special procedure to establish an only representative?

The issue of becoming an only representative is a question of mutual agreement between the ¿non-Community manufacturer¿ and the natural or legal person established in the European Community who is being appointed as an only representative. When the only representative submits the registration(s) he is advised to submit copy(-ies) of the letter(s) officially assigning him. More information on the duties of the only representative is provided in the Guidance on Registration (Section 1.5.3.4 ¿ Only representatives of ¿non-Community manufacturer¿).

The ¿non-Community manufacturer¿ shall inform the importer(s) within the same supply chain of the appointment of the only representative according to Article 8 (3) of the REACH Regulation. These importers shall be regarded as downstream users.

4.5 Can an only representative represent more than one company?

Yes, an only representative can represent one or several non-EU companies that manufacture substances, formulate preparations or produces articles exporting to the Community, even for the same substance. More information on the duties of the only representative is provided in the Guidance on Registration (Section 1.5.3.4 ¿ Only representatives of ¿non-Community manufacturer¿).

5 Pre-registration

5.1 When can I pre-register phase-in substances?

In order to benefit from the extended registration deadlines for phase-in substances, they need to be pre-registered between 1 June 2008 and 1 December 2008 (inclusive), as detailed in the Guidance on Registration (Section 2.2 on Pre-registration) and in the Guidance on Data Sharing (Section 3.5 - Deadline for pre-registration) or laid down in the REACH Regulation, Article 3 (20), Article 23 and 28. Chapter 1.7 of the Guidance on Registration (Section 1.7.1.1 ¿ Phase-in Substances) advises potential registrants when they should submit their registrations to the ECHA.

5.2 Is it possible to benefit from the specific provisions for phase-in substances, if the substance is not pre-registered by 1 December 2008?

Yes, but only in the case of a first-time manufacturer or importer who manufactures or imports a substance in quantities of 1 tonne or more per year for the first time or manufactures or imports more than one tonne for the first time after the pre-registration deadline (1 December 2008) has passed. In this case, the manufacturer or importer can still benefit from the extended registration deadlines for phase-in substances even though he did not preregister within the deadline for pre-registration. According to Article 28 (6) of the REACH Regulation, first-time manufacturers or importers must preregister within six months after first manufacture or import over the one-tonne threshold, and not later than 12 months before the relevant deadline for registration. First-time manufacturers or importers will therefore have to submit their pre-registration before 1 December 2009, 1 June 2012 or 1 June 2017, whichever is relevant as described in chapter 3.6 of the Guidance on Data Sharing .

The same applies for the production of articles and imported articles that contain a phase-in substance for which registration is required and that is used by the company for the first time.

END of extracts from the ECHA REACh FAQ http://echa.europa.eu/doc/reach/reach_faq.pdf ......

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Conclusions:

[A] A trader outside the EU exporting to the EU is not a manufacturer and so can neither Pre-Register / Register substances in REACh nor appoint an "Only Representative".

[B] A trader inside the EU importing substances into the EU will need to pre-register those metals and their wanted alloying elements by 1 December 2008, a trader importing New Scrap or fully processed Old Scrap, i.e. ready to melt Old Scrap of either non-ferrous or ferrous metals should seriously consider pre-registration.