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Dr Reach

NEW DISCUSSION FORUM WITH DR REACH*

Jul-Aug 10: DR Reach: Should I submit a CSR jointly or separately for registration?

To comment on this column, please email: steffen@chemicalwatch.com

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June 10: DR Reach: Fixed goalposts are vital to REACH implementation

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May 10: Dr Reach: REACH and CLP deadlines – getting it right

Dr Reach looks at the road ahead to the 2010 deadlines and advises on how to avoid many of the potential pitfalls.

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April 10: Dr Reach: Thinking ahead to 2013 and “data poor” substances

Dr Reach predicts growing demand for expert services after the 2010 deadlines as companies prepare to register more "data poor" speciality chemicals.

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March 10: Dr Reach: Intermediates and authorisation – why cause such panic?

The recent ECHA/European Commission paper on the definition of intermediates is thought to have caused panic in the marketplace. Dr Reach argues that suspect intermediates can be dealt with in other ways if all potential REACH control mechanisms are considered.

To comment on this column, please email: steffen@chemicalwatch.com

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February 10: Dr Reach: Harmonisation on substance restrictions under REACH?

Dr Reach argues that "there will always be more than one way to assess a risk" and that REACH will need to allow room for Member States to take different restriction and risk reduction approaches.

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December 09/January 10: Traceability and transparency key to good REACH decisions

Understanding how changes to the legislative text occurred and how we have arrived at certain common interpretations can be crucial to ensuring compliance. Dr Reach argues for more transparency and tracking to help companies to understand outcomes.

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November 09: Tougher product safety laws demand holistic thinking

Product safety laws are increasingly casting a wider regulatory net over the whole supply chain. Dr Reach discusses compliance measures and issues that companies should consider.

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October 09: How much to budget for REACH registration in 2010?

Dr Reach discusses what companies can realistically expect to pay for next year, what to watch out for and potential for reimbursements.

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September 09: Would Paracelsus have liked exposure-based waiving?

Dr Reach article (September 2009)

Dr Reach considers how the REACH Regulation is pushing the boundaries in the use of toxicological concepts such as 'thresholds of toxicological concern' for the purposes of exposure-based waiving.

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July/Aug 09: How REACH is raising the bar for risk management

Dr Reach article (July/August 2009): Click here

The process of implementing REACH has already yielded benefits in terms of forcing companies better to understand the chemicals they use and their suppliers. Dr Reach welcomes these but at the same time warns of unintended consequences if the power of REACH is not deployed wisely.

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June 09: Let’s have a public airing of CLP questions to authorities

Dr Reach article (June 2009): Click here

As companies grapple with the complexities of compliance with the EU classification and labelling (CLP) Regulation in time for the notification deadline of 1 December 2010, Dr Reach calls for a more open discussion of the issues being raised with authorities to speed up the learning process for all firms.

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From Paul Huber, Hewlett-Packard

I have just read the June CW briefing and it seems to imply that Notification under GHS only applies to hazardous substances, however as I read it Notification for the CLP Inventory applies to both Hazardous Substance and substances subject to Registration under REACH. This significantly increases the scope of the requirement, am I missing something?

Dr Reach replies:

"I agree except that the CLP Regulation has its own scope under Article 1. Therefore, there are some reductions but this pales into insignificance compared to the increase in scope."

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May 09: Who are you? - by a REACH consultant

Dr Reach article (May 2009): Click here

The market for REACH consultants and contract research organisations appears to have been the main beneficiary of the Regulation so far. Is there a need for a professional certification scheme for consultants?

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From Jo Lloyd, REACHReady

Certification of REACH service providers was something that REACHReady considered offering in the early days as the chemical industry had already had some bad experiences with sub-standard dossiers being generated by service providers for the ICCA HPV programme.

This was a situation that REACHReady's sponsor organisation, the Chemical industries Association, was keen to prevent as time was not on our side in REACH. However, echoing Chris Eacott's experience, certification can be a costly, time consuming and lengthy process, so we needed to keep it simple. The result was our Approved Supplier programme which we use when making referrals through our free REACHReady Matchmaker service.

All our approved service providers have been through a rigorous approval procedure: checking references, assessing credentials, competence and experience, looking at resource capabilities, funding and insurance commitment and more. It is not certification, but it goes some way in helping those who are having trouble making their way through the hundreds of companies now offering REACH services. Using a REACHReady approved service provider gives some level of confidence that the service provider is competent in the REACH services that they offer. Many service providers who apply never make it through our approval process.

www.reachready.co.uk

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From Chris Eacott, Stewardship Solutions

There are many aspects of your article I agree with. Acting as I do as an Only Representative and Third Party Representative for a number of non-EU & EU companies, it is certainly frustrating to realise that a significant number of consultancies (including IT consultancies), have attempted to set themselves up as SFFs and are confusing matters. However, I doubt many will make much progress provided bona-fide companies with a vested interest in relevant substances continue to take the initiative, and importantly, can be identified as genuine lead registrants. Those SIEFs for which SFFs cannot be identified soon may be another story, and could prove easier pickings for these consultancies. Also, you warn about e-mailshots from consultancies that could only have obtained contact details via the ECHA pre-registration database. Related to this, I’ve noticed Chinese companies have begun targeting me with chemicals to sell! I agree with you that these are totally unacceptable practices.

I am less convinced by your assertion that REACH consultants should require certification, for at least a couple of reasons:

• For some time now, REACH has inevitably presented business opportunities for different types of service-providers – trade associations, legal, testing laboratories, regulatory affairs, product stewardship etc. If their services were not required, they simply would not have any business. So, let’s be clear that many REACH consultants are offering a valuable service to hard-pressed companies and confused business managers and REACH coordinators. Certainly, the issue is how to distinguish the better service-providers from the poorer ones. I do know that word gets around our industry quite quickly, and although there may be a lot of consultancies jostling for market share just now, over time we can expect normal market forces to favour the better ones, and opportunistic ones will fall by the wayside.

• Having been involved in many different types of certification schemes, I am all too aware of their limitations which can include a one-size-fits-all approach, inconsistent approach by different assessors, significant deficiencies in key areas may still be missed etc. I find it hard to believe that a high-quality and widely-accepted REACH service-provider certification scheme could be set up to cover all possible REACH activities – and within a reasonable timescale. Anyway, such a scheme would probably be expensive to operate, and the costs of certification would ultimately have to be passed on to customers, who are already worried enough about REACH costs as it is.

Dr Reach replies:

I respect the points that you make. Reputation and performance usually does sort the wheat from the chaff. Unfortunately, as you point out, this does take time.

I have heard of some rather unfortunate incidents having already occurred. So perhaps my recommendation is already too late, as would be any certification scheme. To some extent, my comment is retrospective. However, are there any measures that could be taken to prevent such future happenings, which ultimately cause unecessary additional costs and headaches to a company?

At least there should be some way established to check that a service provider is aware of the responsibilities that it is taking on and ultimately able to meet relevant requirements for its client. Instead of a certification scheme, perhaps at least as a minimum, a free-to-use (sign-up) register could be set-up that requires the party to read and confirm understanding a set of basic facts.

I think that even the fundamentals are often not being understood/ followed. On the other hand, some of these basics have been rather unclear - and even subject to change in interpretations - from the beginning! Therefore a notification process could be linked to a register, for instance - each time there is a potential relevant piece of information/update issued by authorities, listed parties are alerted.

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Apr 09: Dr Reach - Claiming due diligence for substances in articles

Dr Reach article (April 2009): Click here

Meeting the contradictory and confusing demands of the REACH Regulation on obligations to notify substances in articles is difficult enough without the current dissent between some Member States and the European Commission on their legal interpretation. Dr Reach argues that companies may have little choice but to claim due diligence.

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Comment from Christoph Peschek, Abbott Laboratories

You wrote in CW Briefing April 09:
"With direct and immediate effect, Article 33 impacts global supply chains. As soon as a substance is added to the Candidate List, its presence if above 0.1% w/w must be communicated under REACH. The only other clause in the Regulation that specifically relates to SVHCs in articles above 0.1% w/w is Article 7. By contrast to the immediate obligations triggered by Article 33, the notification requirement in Article 7 only starts from 1 June 2011. In addition, there are various limitations to the scope of Article 7, such as tonnage, exemptions to Title II (eg medical devices, food packaging), and exclusions if a substance is already registered for a given use."

• I am aware of the exemption from Title II in Art. 2 (5)a for medicinal products, but not on any exemption from title II for medical devices".
• I am also not aware of some exemption from title II for food packaging, although there are all kind of substances contained in food exempted by Art. 2(5) b (i) and (ii). Is food packaging somewhere hidden included e.g. as part of the scope of these directives? Otherwise I would refer to the ECHA Guidance on Articles stipulating in Section 2.7 “The packaging material does not belong to the substance/preparation or article being packaged.”

Dr Reach replies:

You are absolutely correct. There is no blanket exemption for medical devices and food packaging to Title II.

By comparison, there is a far more straightforward exemption for medicinal products and food additives to Title II. So those would have been much better examples… but less debatable!

I think there can be some scope for 'exemptions' or 'exclusions' from the notification requirements for medical devices and food contact materals. But these are through exposure-baseed waiving and already registered uses. In some cases, the latter may be based on 'deduction' rather than strict demonstration.

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Comment from Melih Babyigit, CRAD, Turkey

In your article in CW Briefing April 2009 you stated: "By contrast to the immediate obligations triggered by Article 33, the notification requirement in Article 7 only starts from 1 June 2011. In addition, there are various limitations to the scope of Article 7, such as tonnage, exemptions to Title II (eg medical devices,food packaging), and exclusions if a substance is already registered for a given use."

But ECHA stated in November 2008:

EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present above 0.1% (w/w) and its quantities in the produced/imported articles are above 1 tonne in total per year per company.

• For substances included in the Candidate List before 1 December 2010, the notifications have to be submitted not later than 1 June 2011.
• For substances included in the Candidate List on or after 1 December 2010, the notifications have to be submitted no later than 6 months after the inclusion.

And in the original text of legislation it states: "From 1 June 2011 paragraphs 2, 3 and 4 of this Article shall apply 6 months after a substance is identified in accordance with Article 59(1)."

May I request your comments if ECHA declaration is wrong or if there is a logic fault in the original text of legislation?

Dr Reach replies:

I think that ECHA will indeed accept SVHC notifications before 1 June 2011. However, as you show in your email, the legal text does indeed state that the requirement applies from 1 June 2011. In order to enable companies to be compliant on 1 June 2011 onwards, ECHA must make it possible to submit notification prior to the date - for practical reasons (e.g. IT). So I don't think there is any real contradiction between the regulation and the guidance. Your observation is however very astute.

My impression is that the legislation basically tends to say that ECHA should make IT and other methods available to help companies comply. So ECHA has some flexibility to set up and start the system when it sees appropriate.

On that note, I have not examined ECHA guidance or Reach-IT in much detail lately, but I don't think that they have this feature available yet (although it is now 6 months after the first Candidate List). Certainly, it would not make much sense for anyone to start submitting notifications until after Dec 2010. Only after the first round of registrations would it really be efficient to check on whether a SVHC has 'already been registered for that use'. This update on the RIP will present some interesting guidance on how companies may check if a SVHC has 'already been registered for that use'.

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Comment from Dr. Körtvélyessy Gyula, Honorary Secretary General for the Hungarian Chemical Society

The main point is, that immediately after the publication of any SVHC in the candidate list, each company in the supply chain shall inform on the following supply (e.g. the following day) each of their customers about the higher than 0.1% presence of this substance in the product supplied. In other wording: none of the companies in the supply chain is allowed to wait for this information from its supplier. Even though only the first supplier in the chain which "fills" the SVHC into a part of the article or into the whole article (e.g. cover it with paint containing candidate list substance) can have information from the SDS about the SVHC present in the chemical this company uses when managing the part or the whole article.

The Guidance document and also the legal text of art. 33 is clearly stating this fact, but nobody cares it in the practice.

Dr Reach replies:

You make an interesting observation. Certainly, I think there is a mixed 'response' across companies. Undoubtedly many were unprepared. Moreover, I think that many are still ignorant of the obligation and may even misunderstand the requirement (e.g. erroneously assuming that a 1 tpy threshold applies).On the other hand, many companies are complying with Article 33 and also preparing well in advance for the addition of future SVHCs. For instance, as you are undoubtedly aware, there are now various potential SVHC lists that companies are using e.g. the Global Automotive Declarable Substance List.

I think this raises a wider debate on 'know your products' and how to set product specifications. This is something that design experts such as those at Rapra have been working on for years, even decades. Through appropriately detailed product specifications, the final supplier/retailer is thereby indirectly involved and linked to the original manufacturer through the supply chain. Legislation has already reached this sort of level in some areas (e.g. food contact materials) and is fast approaching in others (e.g. new toys directive).

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Mar 09: Dr Reach - Common sense needed for reaction mass registration

Dr Reach article (March 2009): Click here

ECHA guidance on identification and naming of substances gives little help on how to register reaction masses. With current confusion on the most appropriate approach, Dr Reach hopes for pragmatism on the part of companies and enforcement authorities. What are your views?

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Comment from Rolf Schneider, Consultant, formerly at Siemens.

There are some issues where I have an understanding of the REACH text which differs from the ones expressed in guidance the ECHA documents. One example concerns the substance identity.

However, at the end each company has to make its decision based on their own interpretation of the regulation thus providing and laying the groundwork for its legal defense if challenged by the authorities.

Definitions in the REACH Regulation
In Article 3.1 the term "substance" is defined as follows in the REACH Regulation:

"Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition."

The REACH Regulation does not make any further statements regarding the type of manufacturing process (e.g. chemical reaction or extraction), or the possible or permitted number, composition or identification of manufactured substances or products. The term "manufacturing" is defined in Article 3 no. 8 solely as:

"Manufacturing: means production or extraction of substances in the natural state"

From this follows that also several substances can form in manufacture or in a manufacturing process. In this case, a mixture of two or more substances would be the outcome of the manufacturing process.

Article 3.2 gives the definition of the term "preparation":

"Preparation: means a mixture or solution composed of two or more substances"

Practically, this means that the terms "mixture" and "preparation" are used as synonyms under REACH. The term "preparation" comprises all types of substance mixtures.

The REACH Regulation makes no distinction between the different origins or production methods of preparations. Consequently, a preparation can be manufactured in many different ways, e.g. by mixing substances, or in a chemical reaction where several substances form and lead to a mixture of substances (= preparation), or by extracting substances from natural materials. Moreover, the definition does not stipulate that only intentional mixtures can be deemed as preparations.

According to Article 6 (1), which was quoted earlier in the Introduction,

"any manufacturer or importer of a substance, either on its own or in one or more preparation(s), in quantities of 1 ton or more per year shall submit a registration to the Agency."

Thus the registration requirement applies both for substances on its own which are manufactured in or imported into the EU, and for substances which are manufactured in preparations or imported in preparations into the EU. Furthermore, in Recital 45 the REACH Regulation points to "complex reaction products":

"The European Inventory of Existing Commercial Chemical Substances (EINECS) included certain complex substances in a single entry. UVCB substances (substances of unknown or variable composition, complex reaction products or biological materials) may be registered as a single substance under this Regulation, despite their variable composition, provided that the hazardous properties do not differ significantly and warrant the same classification."

This Recital is not legally binding, but it indicates that complex reaction products can be seen - but do not necessary need to be seen - as one substance.

II.2 ECHA "guidance for identification and naming of substances under REACH"

The guidance additionally introduces, inter alia, the term "constituent":

"Constituent: Any single species present in a substance that can be characterized by its unique chemical identity" and the term "multi-constituent substance":

"Multi-constituent substance: As a general rule, a substance, defined by its composition, in which more than one main constituent is present in a concentration 10% (w/w) and < 80% (w/w)."

The REACH Regulation does not include these terms. The term "compound" is not explained more closely in the Guidance, even though this could have been expected, because it is an essential element of the substance definition in the REACH Regulation. The first part of the definition of the term "preparation" is correctly repeated in the guidance, reflecting Article 3 no. 2 of the REACH Regulation:

"Preparation: Mixture or solution composed of two or more substances"

But then the guidance, in a comparison with the REACH Regulation, surprisingly makes severe limitations. Initially the following is stated, in a by-the-way manner, in a footnote on page 13:

"Note: Mixtures/preparations are not the same as multi-constituents substances. Multi-constituent substances are named as "reaction mass of …". Multiconstituents substances are the result of a chemical reaction, while no intentional chemical reaction occurs when making a preparation." This introduces the new term "reaction mass".

Moreover, elsewhere in the text (page 23) the definition of the term "preparation" is limited:
"Preparations, as defined in REACH, are intentional mixtures of substances and are consequently not to be considered as multi-constituent substances."

In a further footnote (page 24) it is stated that:

"The difference between preparation and multi-constituent substance is that a preparation is gained by blending of two or more substances without chemical reactions, a multi-constituent substance is the result of a chemical reaction"

Then on page 25 it is said that:

"REACH requires the registration of a substance as produced. If a multiconstituent substance is manufactured, the multi-constituent substance needs to be registered. It is a case by case decision to establish to what extent the different steps in producing the substance are covered by the definition "manufacturing."

All substances covered previously by EINECS (e.g. multi-constituent substances were covered if all individual constituents were listed on EINECS) would qualify as phase-in substances."

Finally, an example on page 49 of the guidance explains what precisely is meant:

"REACH instead requires the registration of the manufactured substance. It is a case by case decision to establish to what extent the different steps while producing the substance are covered by the definition "manufacturing" (e.g. different purification or distillation steps). If a multi-constituent substance is produced it has to be registered (and is not covered by a registration of the individual constituents); e.g. the isomeric mixture diflurobenzene is produced, thus "diflurobenzene", as an isomeric mixture, has to be registered. However, for multiconstituent substances, there is no need to test the substance as such, if the hazard profile of the substance can be sufficiently described by the information of the individual constituents. If the individual isomers 1,2-Difluorobenzene, 1,3-Difluorobenzene and 1,4-Difluorobenzene are produced and mixed afterwards,the individual isomers have to be registered and the isomeric mixture would be regarded as a preparation."

This would mean that according to the guidance, a mixture of substances (in this case of isomers) would have to be named differently and registered, depending on the manufacturing process. Irrespective of the fact that both are identical mixtures of substances (and both are called "mixture" in the guidance), only the latter mixture of previously separate isomers could be seen as a preparation, while the other mixture, formed from a chemical reaction, would be regarded as one substance - namely a "multiconstituent substance".

In this exclusivity and absoluteness, this is certainly an overly narrow interpretation of the REACH Regulation. As expounded above, the REACH Regulation contains no restrictions concerning the type of manufacturing process in which substances and preparations can be obtained and no restrictions concerning the number of substances resulting from a manufacturing process.

According to the definition in Article 3 no. 2, all mixtures of substances (i.a. also mixtures of isomers) can be regarded as preparations.

Practically, the ECHA guidance also denies the manufacture of substances directly in preparations, even though this is expressly provided for by the REACH Regulation in Articles 5, 6 and 86. Moreover, the rule of the guidance that substances occurring in mixed form (e.g. after the manufacturing process) are not preparations ignores the fact that Article 3 no. 2 does not require intentional blending for a mixture to be a preparation.

For this reason, the rules of the ECHA guidance would considerably restrict the flexibility given in the REACH Regulation.

Note: The ECHA guidance allows, in "justified cases", the pre-registration or registration of individual "constituents" of a reaction product as separate substances. In the data requirements for individual "constituents", however, the total "reaction mass" and not the really manufactured volume of the "constituent" - is to be taken into account (see example below). Again the question arises how this requirement is reconcilable with the REACH Regulation. In the REACH Regulation no points are found which would justify this requirement.

It is also worth stating that users of the guidance will barely understand the importance and the consequence that these rules of the guidance might have in practice, e.g. for pre-registration and registration at a later stage - due to the unclear and unsystematic picture given of the connections between the terms "substance", "compound", "constituent", "preparation", "mixture" and "multi-constituent substance" (where important aspects are mentioned only in footnotes; see above comments). It is almost bound to happen that companies do not become aware of the alleged borderline between "multiconstituent substances" and preparations, which is newly introduced in the Guidance.

General conclusions The REACH Regulation makes no restrictions as to the type of manufacturing process for obtaining substances and preparations. Consequently, the ECHA guidance inadmissibly reduces the flexibility given by the REACH Regulation. The above-describedrestrictions through the ECHA guidance would practically lead to a situation where the result of a chemical reaction - i.e. the reaction product - could not be seen as a preparation but would have to be generally viewed as a so-called "multi-constituent substance", i.e. one single substance. In other words, in all cases the guidance allows one to obtain only one single substance as product of a chemical reaction, with this product requiring pre-registration or registration. The possibility of several substances forming in one reaction and of viewing the thus obtained mixture as a preparation is not permitted.The guidance fails to explain how these interpretations can be reconciled with the REACH Regulation.

Comment from Dr. Joseph Plamondon of Bergeson & Campbell

First, I would think that the authors of the regulation addressing this issue had in mind what are called UVCB or Unknown or Variable compositions, Complex reaction products, and Biological materials in the U.S. In these cases, one might be able to define clearly what one starts within terms of reactants, but not in terms of products. Thus, the designation of A, reaction product, with B would be used. In the cases you cite, however, the products are discrete chemical substances that are well defined and existing chemicals.

The basic principle of One Substance One Registration would seem to be violated by requiring duplicate registrations of substances depending on whether they exist alone and in mixtures or are the result of a reaction product. One might ask whether there is any possible risk associated with the substances produced through a reaction process as opposed to a simple mixing of the two, and I would be hard pressed to think of a good reason. On the other hand, it is possible that a mixture or preparation of two substances which are inherently safe on their own could produce toxic properties when mixed together. Because this possibility is ignored by not requiring the registration of mixtures, it should also not be required that components of a mixture simultaneously present due to a reaction be separately registered.

As a final comment, nearly all chemicals are synthesized by reacting two precursor chemicals together, with the resulting chemical accompanied by byproducts, such as water in the cases you present. This would lead to an unmanageable (and unnecessary) situation in which so many substances would have to be registered that it would be akin to having to register all mixtures or preparations.

http://www.lawbc.com/other_pdfs/plamondon.pdf.

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Feb 09: Dr Reach - Focus on data sharing aims to streamline SIEF formation

Dr Reach article (February 2009): Click here

The pressure is on companies that need to meet the 2010 registration deadline to move fast with sameness of substance and data-sharing discusssions within SIEFs. Dr Reach suggests ways to streamline discussions by keeping a focus on the aims of registration.

Jan 09: Dr Reach - Does double pre-registration make sense?

Dr Reach article (January 2009): Click here

Dr Reach discusses the ongoing challenges posed by the requirement for double pre-registration and invites Chemical Watch readers to offer their responses, advice and experiences. Please state if you wish to remain anonymous.

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Comment from Fiona Smith, Regulatory and Registration Manager, Lucite

Lucite has drafted the attached summary and believe that, when it comes to registration, it is possible for a non-EU manufacturer to register and support their downstream users provided that the OR can document the tonnages imported directly or recorded by trustees. We also feel that this obligation can be used to confirm that the pre-registration has been in the correct tonnage band during the phase-in period and that pre-registration in the supply chain is appropriate demonstration of REACH compliance until the full registration is due. To see our full arguments, click here.

Lucite REACH and You site

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Comment from Mike Penman, Penman Consulting

Many thanks for the explanations though I'm still not convinced there are is any need to consider a pre-registration for a monomer where the supply chain has already pre-registered the monomer, although I hear what you're saying.

My great concern is that the degree of over interpretation going on. My experience of regulatory affairs if you take reasonable decisions based on intentions the legislation you don't go far wrong, the intention of pre-registration is to share animal data and come to agreement on classification and labelling prior to a registration -- it is has turned into something quite different and unexpected and something in its own right. The problem with REACH is that everyone to makes it more complicated -- the reality is if people struggle at this level then they'll have a harder time when it comes to the highly complex registration.

However I quite appreciate that people are nervous therefore the “safe” route is what people are going to follow and perhaps we need to advise accordingly. Rather ironic when the whole chemical industry has been railing against precautionary principle so many years! Also when you consider that the whole reason for REACH is chemical safety or adequate control, now we have to do things to make our businesses safe from regulatory activity.

Being very parochial, how I shall manage this inside mega-SIEFs - when there now will be a whole raft other actors have no intention of doing any registration is going to be a real challenge. I agree with you the first thing to do as you say will be to weed them out. For me the large SIEFs are going to be more of a case of megaphone diplomacy rather than one democratic decisions. Effectively, with only 18 months left to have the registration dossiers complete, it will be time to stop worrying about issues and get on with the implementation otherwise they are setting themselves up for failure.

Mike Penman, Penman Consulting BVBA, Belgium

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Previous Dr Reach Q&A columns:

Do third party representatives ensure confidentiality?

Question: Will the identity of a registrant that has appointed a 'third-party representative' be made visible to others at the time of registration?

Dr Reach answer (November 2008)

Candidate List substances in articles

Question: What are the requirements for communicating Candidate List substances in articles?

Dr Reach answer (November 2008)

How are nanomaterials to be registered under REACH?

Question: How are nanomaterials managed under REACH?

Dr Reach answer (October 2008)

What legislation does REACH replace?

Question: What are the 40 Directives and Regulations that REACH is said to replace?

Dr Reach answer (October 2008)

When is a substance a polymer?

Question. Does a substance meet the definition of a polymer under REACH?

Dr Reach answer (September 2008)

How much does registration cost?

Question: "How much will REACH Registration cost?" Question from a Brazilian producer of speciality chemicals.

Dr Reach answer (July/August 2008)

Monomers in an imported polymer

Question: "How can a company register monomers bound in an imported polymer?" Question from a medium-sized Turkish company.

Dr Reach answer (July/August 2008)

Substance, polymer or preparation?

Question: "A company imports a product that contains a polymer and other additives. Is this a substance, preparation or polymer and what must be registered?" The questioner is a Hungarian trade association.

Dr Reach answer (June 2008): Click here

Substances and preparations

Question: "Does a company purchasing 0.5 tonnes of substance A in preparation X and 0.5 tonnes of substance A in preparation Y need to register substance A?" The questioner is a Japanese consulting company.

Dr Reach answer (June 2008): Click here

Natural substances

Question: "How can one identify chemically modified naturally occurring substances?" The questioner represents a Chinese REACH centre.

Dr Reach answer (April 2008): Click here

Candidate list

Question: "How many substances will be included in the 'candidate list' and when?"   The questioner is a regulatory consultancy in the USA.

Dr Reach answer (April 2008): Click here

Paint producers

Question: "Do paint producers have to register substances?" The questioner is a small EU paint producer based in Portugal..

Dr Reach answer (March 2008): Click here

Only representative

Question: "Can a company change the EU company that it wants to act as the Only Representative?" The questioner is a Chinese trade association.

Dr Reach answer (March 2008): Click here

Process gases

Question: "How can one interpret 'process gases and components thereof' as it appears in point 7 of the REACH Regulation Annex V?" The questioner represents a large chemical producer in Poland.

Dr Reach answer (January 2008): Click here

Information for pre-registration

Question: "What information is required for pre-registration of substances under REACH?" The questioner represents a multinational speciality chemicals firm based in Germany.

Dr Reach answer (December 2007): Click here

Biocides and REACH

Question: "Do biocides need to be registered under REACH?" The questioner is a global speciality chemicals manufacturer based in the USA that also exports to the EU.

Dr Reach answer (December 2007): Click here

Intentional release

Question: "Is a scented candle considered an article with a substance which is intentionally released under normal or reasonably foreseeable conditions?" The questioner represents an Italian regulatory and scientific consultancy.

Dr Reach answer (November 2007): Click here

REACH registration and imports

Question: "A non-EU company supplies my EU-based companies with products. Who is then responsible for any REACH-relevant obligations for the registration of the substances in those products?" The questioner represents an SME metals trader based in Italy.

Dr Reach answer (November 2007): Click here

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