Assent July 10 Webinar - June 2012's New SVHC's


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QA Associated with July 2012 Webinar

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Assent July 10 Webinar - June 2012's New SVHC's

  1. 1. Assent Compliance – Webinar – FAQsWebinar title: REACH – June 2012’s New SVHCsDate: July 10th, 2012Q: How much does it takes to notify and to complete the authorization procedure for SVHC? How much does the authorization costs (ECHAfees, consultation etc)?A: Firstly, I will answer the question on Notification – it is essentially a much smaller registration dossier BUT it takes some time to assesswhether notification applies and gather the information necessary to complete the dossier, the actual dossier completion is not overly time-consuming. There is no fee associated with submission.Secondly, I will provide further information on authorisation applications. Authorisation Applications (dossiers) are created in IUCLID (same asREACH Registration dossiers and CLP notification dossiers) however they are NOT submitted in REACH-IT, they use a webform via the ECHAwebsite. They include a CSR, an alternatives analysis, a socio-economic analysis and a substitution plan. Applications must be submitted 18MONTHS before the sunset date and because of the work required, application creation should start at least 30 MONTHS (2.5 YEARS) beforethe sunset date.As for costs, the ECHA webpage “Questions and Answers on applications for authorisation”( summarizes the situationperfectly: Several scenarios can be envisaged: A base fee is payable, which covers one applicant and one use. For each additional applicant, an additional fee per applicant applies. In addition, an additional fee applies for each additional use. For example, in the case of an application submitted by four parties with ten uses in total, the relevant fee will be the base fee + three additional applicant fees + nine additional use fees. The level of the base fee and the additional fee per use depends on the size of the companies that are part to the application. It is important to note that, if you are an SME that is party to an application with other parties that are not SMEs, the standard levels of fees set out in Table 1 of Annex VI of the Fees and Charges Regulation will apply. Likewise, the reduced fees for micro companies set out in Table 4 only apply when all parties to the application are micro companies. However, the level of the additional fee per applicant depends on the applicants size, regardless of the size of the other parties to the application. For instance, if you are a micro company and you apply for an authorisation with large corporations, the reduced fee per additional applicant that applies to micro companies is still applicable to you.Consultancy costs are difficult to estimate without more information on the substance or substances requiring authorization and theinformation available on those substances. If Assent Compliance was furnished with this information, we could provide a firm quote forconsultancy costs.
  2. 2. Q: On the Authorization Process, is Step 3 the "Proposed Candidate List"?A: Yes, step 3 would be considered the Proposed SVHC Candidate List that is published to gather comments from stakeholders. No legalobligations arise at this stage.Q: Are there specific concentration limits for SVHC that are on the authorization list?A: No there are no specific concentration limits for SVHCs that are placed on the authorization list. There can be exempted uses but noexempted amounts/concentrations unless they are prescribed as part of the exempted use. Any presence of the substance from theauthorisation list in a use that is not exempt and does not have an authorisation from the ECHA is considered non-compliant.Q: So a new SVHC is in my article if it is 10, 000 ppm but less than a ton…I dont have to tell my customers? Or I just dont have to notifyECHA?A: Any SVHC in a product at concentrations exceeding 0.1%w/w must be communicated immediately to professional customers and within 45days of a request by a consumer.The calculation of tonnage, to determine your notification obligation, is based on the total of the SVHC in all products produced or importedby a producer/importer in one year. This means that if the SVHC appears in multiple products, the amounts must be calculated throughoutthe products and then that tonnage must be used to determine if the notification requirement applies.Q: If a manufacturer has already submitted a letter of declaration and the newest additions are chemicals not contained in themanufacturers products, does that manufacturer have to refile a letter of declaration when the REACH list is updated even though none ofthe latest additions are in their products?A: To follow due diligence and to ensure compliance is met, it is essential that declarations from suppliers are always based on the mostcurrent SVHC list. A supplier could submit an entirely new letter, update their previous letter or submit an amendment to the existing letterwhich only addressed the newest additions to the SVHC list (as it is assumed the previous letter addressed all the previous SVHC CandidateListed substances).Q: Are there practical (i.e. inexpensive) testing methods for detecting the presence of and/or measuring the amount of these (or any) SVHCs,because presumably many are not used homogeneously in end user products?A: Testing is never the first step in compliance to REACH. Supplier Declaration gathering (for components and parts not produced internally)combined with analysis of any manufacturing materials information (for components and parts produced internally) are the first steps beforeever determining that testing may be needed. Assent Compliance develops a plan that begins with these steps and uses testing as a lastresort for high priority products as well as a Quality Assurance (Due Diligence) check to ensure suppliers are accurate in their declarations.As far as inexpensive testing methodologies go, utilizing a “spectral storage” approach to testing will decrease the cost of future test resultsfor changes in the SVHC list.Q: For SVHCs with two or more CAS numbers, how do we report the SVHC?A: For SVHCs with multiple CAS and/or EC Numbers, it is easiest to think about them as multiple entries to the list and report on each CASnumber/EC Number. When investigating the presence of SVHCs in products, you want to ensure you are verifying for every CAS/EC numberlisted.
  3. 3. Q: For cadmium section 23 of ANNEX XVII, I understood that the wording was updated in May 2011 and the references to colourant wereremoved so this section becomes more wide ranging. Have I understood this correctly?A: There was an update in May of 2011. In the presentation I was working with the original restriction simply as a reference to the fact thatCadmium restrictions previously existed in the European Union (and had existed for years) but that this has no bearing on the reality that acommunication obligation will come into effect when Cadmium (and the other cadmium substances) are added to the SVHC Candidate List.The update can be found at few things were intended with this update:1) The European Commission (EC) wanted to increase compliance with the objective of combating cadmium pollution (this objective has beenin place since 1988). In wanting to further comply with this objective, it was stated that the prohibition of the use of cadmium should beextended to all articles made from PVC in order to comply with the objective of combating cadmium pollution. Because a restriction oncadmium had existed since 1976 and came into force in 1992 (under Directive 76/769/EEC) and then this Directive was repealed to fall underthe “umbrella” of REACH, it took some time to put this amendment into place. • Under this intention (and to simply answer your question), yes the word colorant was removed from paragraph one which means that the presence of cadmium in PVC-related products and mixtures for any reason is restricted. • To see the remainder of the changes for paragraphs 1-4, please visit the link above.2) The EC also wanted to deal with Cadmium’s disturbing presence in brazing sticks and jewellery as these meant a high exposure risk toconsumers (including children), professionals and hobbyists. • New paragraphs were added to the restriction – paragraphs 8-11. These can also be further examined by clicking on the link above and downloading the amendment.Q: If I have an electronic component (article) that contains >0.1% of a SVHC, my obligation is to disclose to our customers the name of theSVHC for that particular part. What about the requirement for a SDS? If the SVHC is bound and no chance for release, does a SDS need to becompleted?A: EU & EEA suppliers of a substance have to provide a safety data sheet to their customers when the substance is on the SVHC CandidateList. Furthermore, EU and EEA suppliers of a preparation not classified as dangerous according to Directive 1999/45/EC have to provide therecipients, at their request, with a safety data sheet if the preparation contains at least one substance on the Candidate List and its individualconcentration is at least 0.1% (w/w) for non-gaseous preparations and at least 0.2% by volume for gaseous preparations.Q: Does identifying the substance in a product MSDS provided to the downstream user satisfy the requirement to notify? Does the substanceneed to be specifically identified as a SVHC?A: An MSDS or SDS is normally used for substances and preparations. In that scenario, the MSDS/SDS is already required to include SVHCsthat are present. If the supplier of an article chooses to use an MSDS as a communication method then as long as the SVHC is named and safehandling instructions are included, the requirements would appear to be met.
  4. 4. Q: When known uses of a SVHC are listed, is it implied that those uses are known to exceed 0.1% w/w of the listed articles?A: It is not implied that these uses are known to exceed 0.1% w/w in the listed products or articles, these uses could combine in certainproducts to easily exceed 0.1% for one SVHC, multiple SVHCs or remain under the 0.1% w/w threshold.Q: Please include possible presence of new SVHCs in packaging materials and not just that within EEE.A: In this webinar and the uses lists, the focus was not on EEE but on all industries impacted by the new SVHCs, the intended SVHCs and eventhe authorization list. Packaging is considered a separate article and therefore the 0.1% w/w threshold applies to each level of packaging of aproduct. Of course the fact that plastics, resins and adhesives are some of the most likely items to contain SVHCs means that plasticpackaging is at very high risk to contain SVHCs.Q: If our products do not intentionally emit SVHCs during normal use, do we have to go through the Notification process even if more than0.1% wt.?A: Article 7.3 of the REACH Regulation does provide for an exposure-based exemption from the notification requirement:Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonablyforeseeable conditions of use including disposal. In such cases, the producer or importer shall supply appropriate instructions to the recipientof the article.The Guidance on requirements for substances in articles, section 6.3, further expands on this exemption:Exposure to a substance in an article is possible even if the substance is not released from the article, but just on the surface of it. Therefore, aproducer/importer wanting to demonstrate ‘exclusion of exposure’ has to ensure that the SVHC on the Candidate List does not come intocontact with humans or the environment, regardless of its dangerous properties. Note that all exposure routes at all life cycle stages have tobe considered (service life of the article and waste stage).…Note that it may be more difficult and costly to demonstrate “no exposure” than making a notification.REACH does not require documentation to be provided to the ECHA to support an exemption from notification. However, shouldenforcement authorities request information justifying the lack of a notification, then documentation should be available. Information onwhat a justification should include is available in the same section 6.3 of the guidance.
  5. 5. Q: Are there any exemptions for notification of SVHCs?A: From the “Guidance on the requirements for substances in articles”:A number of substances are exempted in general (i.e. whether on their own, in mixtures or in articles) from registration and notification assufficient information is known about these substances or registration and notification are simply deemed inappropriate or unnecessary(Article 2(7)(a) and (b)). Annexes IV and V of the REACH Regulation specify which substances these are. The Navigator on the ECHA websitecan be used to check if any exemption based on an entry in Annex IV or V applies and a registration or notification under Article 7 wouldtherefore not be required.The REACH Regulation exempts substances which are recovered in the EEA from registration and notification, provided a number of conditionsare met (Article 2(7)(d)). Producers of articles made of recovered substances can therefore in principle benefit from this exemption. Theconditions set by REACH which have to be respected in order to benefit from this exemption are described in section of the Guidanceon registration.According to Article 7(3), notification is not required if the producer or importer of articles can exclude exposure to humans or theenvironment during normal or reasonably foreseeable conditions of use19, including disposal.According to Article 7(6) a registration or notification of a substance in articles is not required, if the substance has already been registered forthat use (i.e. the process by which the substance is included in the articles). This refers to any registration of that use of the substance in thesame supply chain or any other supply chain.A substance has already been registered for a particular use, if two conditions are fulfilled:• The substance in question is the same as a substance that has already been registered.• The use in question is the same as one of the uses described in a registration of this substance that was already made.It is important to be aware that the use of any of these exemptions will require extensive due diligence to ensure all applicable conditionsare met.Q: Are there any exemptions for authorisation?A: It is not technically an exemption but there is a scope consideration when dealing with authorisation that is extremely helpful to importersand non-EU producers who sell to the EU - Substances that are an integral part of articles imported to the EU, and not intentionally releasedfrom the article, are not subject to Authorization.Other than this scope consideration, there are no overall exemptions for authorisation, any exemptions are on a per substance basis andrefer to a specific sector or use. Currently, BBP, DEHP and BBP do have a uses exemption: Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.
  6. 6. Q: What is the timeline between a sunset date and the application deadline? A: An applicant is required to submit their application at least 18 months before the sunset date. The current Authorisation List, with the associated sunset dates and application submission deadlines, is: Application SUBSTANCE NAME EC NUMBER CAS NUMBER Sunset Date Deadline Aug 21, 20144,4- Diaminodiphenylmethane (MDA) 202-974-4 101-77-9 Feb 21, 2013 Feb 21, 2015Dibutyl phthalate (DBP) 201-557-4 84-74-2 Aug 21, 2013 Feb 21, 2015Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Aug 21, 2013 Feb 21, 2015Bis (2-ethyl(hexyl)phthalate) (DEHP) 204-211-0 117-81-7 Aug 21, 2013 May 21, 2015Diarsenic pentaoxide 215-116-9 1303-28-2 Nov 21, 2013 May 21, 2015Diarsenic trioxide 215-481-4 1327-53-3 Nov 21, 2013 Aug 21, 20145-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 201-329-4 81-15-2 Feb 21, 2013Hexabromocyclododecane (HBCDD)and all major diastereoisomers 3194-55-6identified: 25637-99-4 247-148-4 Aug 21, 2015Alpha-hexabromocyclododecane 134237-50-6 Feb 21, 2014 221-695-9Beta-hexabromocyclododecane 134237-51-7Gamma-hexabromocyclododecane 134237-52-8 Aug 21, 20152,4-Dinitrotoluene (2,4-DNT) 204-450-0 121-14-2 Feb 21, 2014 Feb 21, 2015Diisobutyl phthalate (DIBP) 201-553-2 84-69-5 Aug 21, 2013 May 21, 2015Lead chromate 231-846-0 7758-97-6 Nov 21, 2013 May 21, 2015Lead chromate molybdate sulphate red (C.I. Pigment Red104) 235-759-9 12656-85-8 Nov 21, 2013 May 21, 2015Lead sulfochromate yellow (C.I.Pigment Yellow 34) 215-693-7 1344-37-2 Nov 21, 2013 Aug 21, 2015Tris(2-chloroethyl)phosphate (TCEP) 204-118-5 115-96-8 Feb 21, 2014 Q: Is there a maximum time limit to an authorisation if granted? A: In terms of time limits for authorisations; if an authorisation is granted, there will be a time-limited review period set directly in the decision on authorisation. The holders of the authorisation will be required to submit a review report 18 months before the expiry of the review period.