Verband der Mineralfarbenindustrie e. V.
VdMi
Der Verband der Mineralfarbenindustrie e.
ID: 388728111714-79
Lobbying Activity
10 Apr 2024
Bitte beachten Sie unsere ausführliche Stellungnahme, die wir mit dieser Eingabe hochgeladen haben. Unsere Kernaussagen: Widerspruch in Zusammenfassung und Verordnungsentwurf ! Die neuen Regeln für hohen Reinheitsgrad (high degree of purity) soll es maximal für Stoffe aus Abfällen und natürlichen Materialien geben, so wie seit 2022 angekündigt und 2023 auch kommuniziert, d.h. nicht unerwartet auf alle Stoffe ausgeweitet ! Keine Definitionen von Reinheitsanforderungen mit Migrations-Grenzwerten, die in der Praxis nicht umsetzbar sind (0,15 ppb und 50 ppb). Anforderungen, die zu einem Reinheitsgrad an Rohstoffe für FCM von >99,99999 % führen, sind in der Praxis nicht umsetzbar. Neue Regeln mit hohem Reinheitsgrad sind für Pigmente und Füllstoffe nicht erforderlich, Studien belegen: Es findet keine Migration aus dem Inneren einer Kunststoffmatrix statt. Fazit: Wir lehnen die neuen Grenzwerte ab. Reinheitsanforderungen, die über die Verordnungen (EU) Nr. 1333/2008 und (EU) Nr. 1334/2008 Anforderungen an Lebensmittelzusatzstoffe hinausgehen, sind in der Praxis nicht umsetzbar. Wir schlagen für Pigmente pragmatische Ansätze vor, wie Obergrenzen für PAA, PAH und Metalle. Die Reglungen für Reinheit sind in der (EU) Nr. 10/2011 falsch positioniert, diese Reglungen sollten in der Rahmenverordnung für FCM (EU) Nr. 1935/2004 oder in der (EU) Nr. 2023/2006 gute Herstellungspraxis für FCM enthalten sein.
Read full responseResponse to Measures to reduce microplastic pollution
15 Jan 2024
Bitte beachten Sie unsere ausführliche Stellungnahme, die wir mit dieser Eingabe hochgeladen haben. Unsere Kernaussagen: Maßnahmen zur Vermeidung einer unbeabsichtigten Freisetzung sind bei den Herstellern von Kunststoffgranulaten bestens bekannt und wurden in den letzten Jahren freiwillig und wirkungsvoll umgesetzt. Der unbeabsichtigte Verlust von Kunststoffgranulat ist nicht gleichzusetzten mit dem tatsächlichen Eintrag von Kunststoffgranulat in die Umwelt. In den Unternehmen gibt es bereits innerbetriebliche Rückhaltesysteme. Die Regulierungen im Verordnungsvorschlag bedeuten gerade für kleine und mittelständische Unternehmen (KMU) einen sehr hohen bürokratischen Aufwand und der Nutzen im Sinne der Initiative steht damit in keinem Verhältnis. Es muss sichergestellt werden, insofern regulative Maßnahmen tatsächlich eingeleitet werden, dass die beabsichtigten Maßnahmen für kleine und mittlere Unternehmen (KMU) durchführbar sind. Im Verhältnis ist der Eintrag von Kunststoffgranulat in die aquatische und terrestrische Umwelt in Deutschland deutlich niedriger als im Verordnungsentwurf für ganz Europa genannt. Kläranlagen scheiden bis zu 99% des Kunststoffgranulats aus Abwässern in den Klärschlamm ab. Klärschlamm sollte nicht weiter landwirtschaftlich verwertet werden, sondern verbrannt werden. Granutverluste beim Transport auf Straße und Fluss und beim Be- und Entladen von Containern in Häfen bergen das größte Risiko für einen Eintrag in die Umwelt.
Read full responseResponse to Revision of the definition of engineered nanomaterial in food
20 Dec 2023
VdMi, the association representing the producers of pigments and fillers in Germany, thanks the European Commission for the opportunity to comment on the draft Delegated Regulation amending Regulation (EU) 2015/2283 as regards the definition of engineered nanomaterials. We welcome the harmonisation with the Commissions Recommendation of 10 June 2022 on the definition of nanomaterial and the clarification that all manufactured materials, regardless of how and from which starting materials they are produced, would fall under the definition if the particle size distribution contains 50% or more particles with less than 100 nm. As stated in Article 2 of Regulation (EU) 2015/2283, the Novel Food Regulation does not apply to food additives covered by Regulation (EC) No 1333/2008. Therefore, we assume that the definition of nanomaterials is related to novel food. The Regulation (EU) No 1169/2011 on the provision of food information to consumers refers to the definition of engineered nanomaterial in the Novel Food Regulation. The cross-reference only to sub-paragraph (f) of Article 3(2) of Regulation (EU) 2015/2283 removes the definition from the original "purposes of this Regulation" under which it is listed in this article. We would like to recall that the definition of a nanomaterial based on the size was explicitly established without any reference to a potential hazard or change in function or properties. The Regulation (EU) No 1169/2011 on the provision of food information to consumers would require all ingredients and additives falling under the definition of engineered nanomaterial to be labelled with "(nano), even if they are not covered by the Novel Food Regulation. In practice, this would lead to an avoidance and removal of well-tested and approved additives, although there is no hazard related rationale and need to do so. This issue is not addressed in the current draft. As long as there is no amendment of the Food Information Regulation in sight, we suggest as a workaround to include in the definition the relevant limitation to the novel properties addressed in the Novel Food Regulation: 'Engineered nanomaterial' means an intentionally manufactured material in the nano-size range to fulfil a new specific purpose or to deliver a new specific function, differentiating it from forms of the same material being on market within the Union before 15 May 1997 and which consists of solid particles that are present [] Thank you for your consideration of this contribution. We remain at your disposal for further discussion. The Verband der Mineralfarbenindustrie e. V. represents German manufacturers of inorganic (e. g. titanium dioxide, iron oxides), organic and metallic pigments, fillers (e. g. silica), carbon black, ceramic and glass colours, food colourants, artists' and school paints, masterbatches and products for applied photocatalysis. The VdMi is listed in the Lobbying Register for the Representation of Special Interests vis-à vis the German Bundestag and the Federal Government (Lobbyregister des Deutschen Bundestags, number R000760) as well as in the Transparency Register of the EU Commission (number 388728111714-79).
Read full responseResponse to Revision of EU legislation on hazard classification, labelling and packaging of chemicals
30 Mar 2023
Bitte entnehmen Sie unsere Position dem angehängten Dokument. Unsere Kernpunkte: Der vorgeschlagene Ansatz der Klassifikation von mehrkomponentigen Stoffen widerspricht dem UN GHS und wird zu schweren Problemen in der Implementierung führen. Wir fordern, dass die Einführung der Definition von mehrkomponentigen Stoffen zurückgezogen wird. Wir befürchten, dass die harmonisierte Einstufung von Stoffgruppen zu einer unzureichenden Einstufung führen wird, wenn die Mitglieder der Gruppe in Bezug auf die Gefahrenbeurteilung nicht eindeutig identifiziert und validiert werden. Statt bürokratische Hürden zu erschaffen, plädieren wir das Einstufungs- und Kennzeichnungsverzeichnis zu schließen und sich auf die harmonisierte Einstufung und Kennzeichnung nach Anhang IV sowie die gemeinsame Einstufung und Kennzeichnung der REACH-Registrierung zu fokussieren, da diese Informationen von höherem Wert sind und eine größere Zuverlässigkeit haben. Wir kritisieren die einseitige Abweichung der EU vom UN GHS scharf, da diese zu großen Herausforderungen für die gesamte Chemieindustrie sowie zu Handelsbarrieren und rechtlicher Unklarheit führen wird. Wir bezweifeln, dass diese Maßnahmen notwendig sind.
Read full responseResponse to Introducing new hazard classes–CLP revision
17 Oct 2022
In course of the EU’s Green Deal and the Chemicals Strategy for Sustainability, both the CLP and the REACH Regulation, EU’s fundamental chemicals’ regulations, shall be revised. The Commis-sion’s aim is to further improve human health and the protection of the environment by providing a legal framework pushing the industry towards so-called safe and sustainable substances. In principle, this means nothing else than tightening the given legislation and introducing new obliga-tions for producer and users of chemicals in the EU.
The currently published draft regulation introducing overall six new hazard classes into the CLP Regulation is only the first step in this process. The Commissions intends to introduce these new hazard classes via a Delegated Act without any further impact assessments or extended consoli-dation periods. From our point of view, this process does not reflect the immense impact such a step would have. Not at least because it poses a solo effort of the EU, contradicting and under-mining the EN’s worldwide standard GHS.
Therefore, VdMi promotes
• No undermining the GHS by going solo – EU’s CLP should follow the worldwide standard instead of introducing new hazard classes which may lead to conflicts in worldwide hazard communication
• Only a wider perspective on all actions proposed within the CSS allows a comprehensive understanding of what purpose the introduction of new hazard classes serves – the Com-mission is using a slice-and-dice tactic to push its goals
• Proper impact assessment including effects on downstream legislation and required animal testing necessary – the proposed changes are not only of technical nature
• Legal and scientific justification for the introduction of the new hazard classes questionable – more appropriate means to handle concerns neglected
Additionally, VdMi proposes the following changes in the proposed legal text
• Criteria for ED category 2 are insufficient, if at all only ED category 1 should be implement-ed
• Relocation of the clarification that PBT, vPvB, PMT, and vPvM only apply to organic and organo-metallic substances to facilitate implementation and avoid confusion
• Change of signal word for vPvB and vPvM to ‘warning’
• Further clarification on specific wordings, especially with regard to the application of Weight of Evidence
• Postponement of start of the transition periods needed until Guidance documents are avail-able. In practice, manufacturers can only start to assess their substances (and sub-sequent also mixtures) after the publication of the Guidance documents.
Contact:
Verband der Mineralfarbenindustrie e. V.
Dr. Heike Liewald / Dr. Giuliana Beck
liewald@vdmi.vci.de / beck@vdmi.vci.de
The Verband der Mineralfarbenindustrie e. V. represents German manufacturers of inorganic (e. g. titanium dioxide, iron oxides), organic and metallic pigments, fillers (e. g. silica), carbon black, ceramic and glass colours, food colourants, artists' and school paints, masterbatches and products for applied photocatalysis.
The VdMi is listed in the Lobbying Register for the Representation of Special Interests vis-à vis the German Bundestag and the Federal Government (Lobbyregister des Deutschen Bundestags, number R000760) as well as in the Transparency Register of the EU Commission (number 388728111714-79).
Read full response11 Aug 2022
This initiative is closely linked to the concept of ‘one substance, one assessment’, strived for under the EU Green Deal and its Chemicals Strategy for Sustainability. This concept promises some improvements in substance evaluation but at the same time it also harbours many pitfalls that might cause serious damage to EU’s industry. Sensitivity, well-considered assessments, and a close exchange with all stakeholders are indispensable for a successful implementation.
Even though the current Call for Evidence does not give many details on how the EU Commission plans to improve the data access, VdMi would like to emphasize several general points of concerns which need to be considered.
Data requirements, data availability, and data sharing
Uniform data formats for submitting information to relevant EU bodies may facilitate data processing and cross-agency data exchange. However, due to the manifold information requirements in the various chemicals and product-related legislations, it is highly important to preserve enough freedoms. Too many mandatory requirements may lead to inapplicability of this format.
With more data being submitted and all available data being used in assessments, it is again highly important to consider all the different requirements in the various legislations. Especially product specific legislation for sensitive applications like food or food contact have much higher requirements on the used materials regarding e. g. purity or migration limits. Materials used in these sectors already fulfil a higher safety standard. When assessing such applications, studies on materials that are not intended for such sensitive uses do not allow for qualified statements on the safety. Identifying relevant studies may be more difficult and time consuming than the current system. High expertise and detailed knowledge of the respective requirements is needed to conduct a reasonable and balanced safety assessment. Even though all available data may be used in the assessment, in many cases considering all available data will lead to wrong conclusions.
Additionally, data and cost sharing become much more complicated if data are being re-used without the data’s owner consent and across legislations. This is a huge barrier for cooperation and thus might lead to unnecessary duplication of already available data or beneficiaries who do not want to pay their share but still benefit from EU’s industry’s efforts and the high standards on chemical’s safety in the EU.
Confidentiality and security
Confidentiality of relevant business information must be guaranteed. Open data platforms always pose a threat to sensible information, even more so, if data are supposed to be shared among different stakeholders.
Additionally, data security is – of course – essential. Moving from data reporting to data harvesting would be really challenging as each individual company would need to adjust their IT systems to allow for external access. This is a huge and unnecessary burden especially for SMEs. There are already systems in place to ensure reporting deadlines are met.
Reporting obligations
Notifying any commissioned study is neither reasonable nor applicable or justified. The Transparency Regulation 2019/1381 which is supposed to act as a role model requires studies supporting an application or registrations to be notified to EFSA. If the scope would be widened to oblige industry to support any study relevant for any legislative requirement, it means worst case that every study would need to be notified including those relevant for quality control. There is no benefit from such a proposal, and it is simply not proportional.
Read full responseResponse to EU rules on industrial emissions - revision
23 Jun 2022
The Industrial Emissions Directive (IED) 2010/75/EU has been in force since the end of 2010, regulating large industrial installations and defining requirements for their permits. It also provides the basis for the "BREF process" in Seville, which resulted in a large number of binding conclusions corresponding to the best available techniques (BAT).
Since its publication, good progress has been made towards the general objective of preventing, reducing or as far as possible eliminating pollution from industrial activities. This progress will be ensured continuously with the existing IED.
The transformation of industry envisaged by the Commission under the Green Deal requires a solid economic situation and opportunities for companies to act in an agile manner. We are of the opinion that some of the Commission's Proposals counteract this.
• Article 15(3) of the Proposal requires the competent authority to set the lowest possible emission limit values of the BAT-AELs range as limit value in the permit. If this is feasible, each operator is required to substantiate this in a separate justification for a higher limit value. This invalidates the results of the BREF process and results in high effort for both, industry and authorities, and massive delays in approval processes.
• Also, the obligation of environmental management systems, transformation plans, and chemicals management systems to be part of the permit results in high bureaucratic effort without providing any added value.
• For benchmarking, comparable plants are required. Especially in our industry sector, production processes are very varied and no plant is identical to another.
• We are concerned about the planned disclosure of confidential data in the BREF process and the publication of the transformation plans. This would harm commercial interests of the operators concerned and entail competitive and industrial espionage risks.
• The planned changes regarding penalties and compensation will undermine national law for our companies and pose the risk of misused legal disputes.
We see the small and medium-sized chemical plants in our industry sector as being particularly affected. With lower profit expectations, they have to face the same challenges as larger companies.
For further details, please consult the position of the German Verband der Chemischen Industrie e. V. (F3317253), which we support.
The Verband der Mineralfarbenindustrie e. V. represents German manufacturers of inorganic (e. g. titanium dioxide, iron oxides), organic and metallic pigments, fillers (e. g. silica), carbon black, ceramic and glass colours, food colorants, artists' and school paints, masterbatches and products for applied photocatalysis.
Read full responseResponse to Sustainable Products Initiative
22 Jun 2022
The Verband der Mineralfarbenindustrie e.V. (VdMi) welcomes the EU Commission's efforts to strengthen the circular economy through the Ecodesign Regulation for Sustainable Products (ESPR), which is part of the 2020 Circular Economy Action Plan, as part of the Green Deal.
Nevertheless, when considering sustainability criteria, the product and its use within the framework of the entire life cycle must be kept in mind, i.e. including performance and functionality. Focusing exclusively on the circular economy is a too limited approach.
Sustainable products also play an important role in the whole chemical industry and therefore, all contributions that help to conserve resources should be taken into account. This also includes the durability of products and their general contribution to climate protection. VdMi as part the chemical industry acknowledges its responsibility in providing chemicals which help achieve a higher sustainability of the final articles, and is working continuously on improving, whenever possible, the performance of its products.
The following aspects mentioned in the proposed ESPR are extremely important:
- Sustainability and hazardous substances are not mutually exclusive: The functionality or reactivity of chemical substances required for this is often inextricably linked to the hazardous properties and does not automatically pose a risk to humans and the environment. The focus must therefore be on the safe and sustainable use of substances and products.
- No restriction of substances under the ESPR: Restriction of substances must be in line with REACH: The current legislation (in particular, REACH) must be considered and creating new legislation should be avoided. E.g., SDS are the documents to inform about hazardous chemicals content to customers and users, and they should remain the reference for sharing information down the supply chain.
- The digital product passport (DPP) does not apply to chemicals and mixtures, therefore the principle of confidentiality must be ensured. Disclosure of information could be critical for chemicals (confidential information and know-how must be protected).
- No disadvantages for European competitors. An effective initiative on products will need to have a clear strategy as regards imports in the EU.
- Sustainability must take into account the ecological, economic and social dimensions within the framework of the entire life cycle: We also support the inclusion of requirements to address social aspects. This will be part of the input requirements on product design and lifecycle analysis (Eco-design). Considering only circular aspects could restrict product innovation and future technical solutions for added value challenges.
Sustainability is part of our industry - Additional aspects to distinguish between products and chemicals
When considering the different contributions to the sustainability of products, chemical substances or mixtures could clearly not be ruled the same way of final products (electronics, textile, households) for which material durability, new features, planned obsolescence, fashion, and so on are relevant parameter to quantify the sustainability aspect.
Chemical substances and mixtures (e.g. VdMi products like pigments, fillers, ceramic colours and masterbatches) will be consumed in the production or incorporated into the final articles to enhance their performance; from this point of view, “successful” chemicals (substances and mixtures) on the market are already the ones increasing the sustainability of the product by improving its quality.
Read full responseResponse to Circular economy monitoring framework - Revision
2 Jun 2022
Aktueller VdMi Standpunkt:
Der Verband der Mineralfarbenindustrie e.V. (VdMi) unterstützt das allgemeine Ziel des Aktionsplans für Kreislaufwirtschaft für mehr Nachhaltigkeit. Es sei erwähnt, dass dieses Ziel von den im VdMi vertretenen Herstellern von Stoffen und Gemischen bereits in den letzten Jahrzenten durch vielfältige Maßnahmen verfolgt wird. Pigmente und Füllstoffe, und diese in Pigmentpräparationen oder Masterbatches verarbeitet, leisten bereits heute einen großen Beitrag zu Langlebigkeit und Qualität von Materialien und Artikeln.
Artikel aus Kunststoff hätten ohne Zusätze zur Verbesserung der Materialeigenschaften eine deutlich geringere Lebensdauer. UV-Absorber verhindern Sprödigkeit, Füllstoffe können die Flexibilität verbessern und den Artikel widerstandsfähiger machen. Solche Eigenschaften werden für langlebige Materialien benötigt, umso mehr, wenn die Materialien immer wieder recycelt werden sollen.
Zum Beschränkungsvorhaben von absichtlich zugegebenem Mikroplastik haben wir uns mit zwei Eingaben im Rahmen der öffentlichen Konsultation beteiligt. Weiterhin wurde mit einem Sachstandspapier klargestellt, dass einige Produkte unserer Mitgliedsunternehmen, die per Definition zu Mikroplastik gemacht wurden, kein Mikroplastik im Sinne des Beschränkungsvorhabens sind.
Der Aktionsplan der EU-Kommission kann unseren Unternehmen vielfältige Chancen bieten, es muss aber unbedingt darauf geachtet werden, dass die neuen Ziele für die Unternehmen umsetzbar sind und die Politik die Industrieunternehmen bei der Ausgestaltung der Maßnahmen miteinbezieht. Zusätzliche Belastungen, die Zukunftsinvestitionen behindern, sind kontraproduktiv, die Attraktivität der europäischen Produktionsstandorte muss erhalten bleiben.
Der Verband der Mineralfarbenindustrie e. V. vertritt die deutschen Hersteller von anorganischen (wie z. B. Titandioxid, Eisenoxide), organischen und metallischen Pigmenten, Füllstoffen (wie z. B. Kieselsäure), Carbon Black, keramische Farben, Lebensmittelfarben, Künstler- und Schulfarben, Masterbatches sowie von Produkten für die angewandte Photokatalyse.
Unsere ausführliche Stellungnahme finden Sie in unserem Positionspapier in Anlage.
Read full responseResponse to Protection of workers health from risks related to exposure to lead and di-isocyanates
18 Mar 2022
As association, Verband der Mineralfarbenindustrie e. V. represents the German manufacturers of lead-containing ceramic colours and frits, amongst others. Our members are predominantly medium-sized companies and employ many long-serving employees.
We can understand the appropriateness to lower the established biological limit of 700 µg lead/L blood, which has been in place for 20 years.
The limit value of 150 µg lead /L blood proposed by the ACSH corresponds to the value introduced in Germany via the TRGS 505. In our view, this value is already ambitious, especially since other life circumstances over which the employer has no influence (such as diet, smoking, hobbies) can have an impact on the blood level.
As already noted by the ACSH, long-serving employees can have blood levels well above 150 µg lead / L blood. Bone deposition and slow release may lead to blood levels remaining persistently high despite taken changes in risk management measures.
We therefore support the position of the Employers Interest Group (EIG) that a sufficient transition period must be introduced to allow a continuing production under regular medical surveillance of workers. Transferring these long-serving workers to different jobs in the company exempt from lead exposure, which would have to take place over several years for a significant reduction of blood levels, is not feasible in small and medium-sized enterprises. Furthermore, we consider a limit value of less than 150 µg lead / L blood to be impracticable.
We are at your disposal for a further exchange.
Read full responseResponse to Simplification and digitalisation of labels on chemicals (CLP, Detergents, Fertilising Products)
13 Sept 2021
VdMi basically supports the use of digital labels, as they offer many options for providing the user with important information in a targeted and uncomplicated manner (see also our position paper file). However, some aspects must be taken into account, especially in the area of very small packagings, in order to really achieve a simplification and not just produce additional effort for the manufacturers.
VdMi has been committed to the possibility of digital labels for several years. For products in the field of artists’ and school colours, it has long been a challenge to accommodate all the necessary labelling elements on small-scale products. Via VdMi and other European associations, the necessity of digitising hazard information for chemical products was introduced to the responsible committee at GHS level already in 2019. The initiative at EU level is therefore welcomed, but a European solution developed here would also have to be incorporated into the GHS.
Digitally stored labelling texts can be updated promptly. Any changes that become necessary due to legal requirements or changes in recipes or raw materials can be incorporated quickly and easily. In this way, consumers always have up-to-date labelling information at their disposal and added value is achieved for hazard communication.
In addition, a digital solution has the advantage that all information on the label could be available in additional languages. Especially when labelling very small packagings, it is imperative that as much relevant information as possible can be stored digitally and no longer has to be on the physical label.
VdMi favours the use of a QR code that leads to the hazard information on the manufacturer’s or product manager’s website. Further information, e.g. on applications, should be optional on the digital label.
It should be borne in mind that a digital label is intended to simplify the process of labelling, warning and informing. There is often no physical space for an additional digital label that only repeats the information already displayed, especially with very small packagings. Applying a digital label would unnecessarily take up space, which is needed for the display of essential information.
Therefore, VdMi promotes:
• Introduction of the possibility of a digital label at GHS and EU level
• Benefit from the advantages of digital labels
Easy updating of relevant data
Provision of additional, legally non-mandatory information, e.g. additional languages
• Improvement of (hazard) communication by reducing the information to essential (warning) notices on the sales product
Relief, especially in the field of small packagings
• No additional overloading of very small packagings due to redundancies
Optimal use of the limited available space
Read full responseResponse to Amending Regulation (EC) No 1272/2008 relating to emergency health response
9 Aug 2019
Der Verband der Mineralfarbenindustrie e. V (VdMi) begrüßt die Möglichkeit einer öffentlichen Konsultation zu Ares (2019)4744568. Wir bewerten die erfolgte Anpassung des pH-Wertes an die Regeln des GHS der Vereinten Nationen und die Verschiebung der Meldefrist für Verbraucherprodukte auf den 1. Januar 2021 als positiv.
Zu einigen Punkten gibt es unserer Einschätzung nach noch keine zufriedenstellenden Änderungen / Lösungen, unsere Eingabe dazu finden Sie in Anlage.
Read full response28 Jan 2019
Verband der Mineralfarbenindustrie e.V. (VdMi) represents the German manufacturers of inorganic and organic pigments, fillers, carbon black, ceramic colours, food colourants, artists’ and school colours, masterbatches, and products for applied photocatalysis. VdMi represents in total 75 companies, about 75 % of the companies are SME’s. The combined annual turnover of the sectors is about 4 billion Euro. VdMi welcomes this public consultation under the Better Regulation initiative. However, the proposed classification of titanium dioxide as carcinogen Cat 2 is disproportionate and the benefit of it has never been demonstrated by the EU Commission. The proposed classification is therefore misleading and would have grave and disproportionate effects for almost all applications – due to the current legal situation also in areas where no inhalation can occur. VdMi rejects the proposed classi-fication of titanium dioxide as a carcinogen Cat 2, as we consider it to be neither justified nor appro-priate. With the classification proposal in our view the attempt is made to classify an individual sub-stance on the basis of substance-unspecific particle effects. This is not in the meaning of the CLP regulation. A classification of titanium dioxide due to particle effects could be used as a precedent for many other substances eventually leading to a classification of many other substances called PSLT with significant and disproportionate impact on our industry.
The classification proposal in the CLH report is based essentially on studies in rats, exposed to ex-tremely high concentrations of titanium dioxide dusts, which led to so-called “lung overload”-effects. All relevant guidance documents by ECHA, OECD and ECETOC unanimously observe that the re-sults from “lung overload” studies in rats should not be transferred to humans for several reasons. Therefore, a classification is neither justified nor appropriate from the toxicological perspective. For justification purposes, we refer to CLP regulation Annex I, 3.9.2.8.1.(e):
“substance-induced species-specific mechanisms of toxicity, i.e. demonstrated with reasonable cer-tainty to be not relevant for human health, shall not justify classification.“
Similar substances such as PSLT’s show the same effects (lung overload). Therefore, these particle effects are not an intrinsic property and, consequently, they should not be addressed under CLP.
Titanium dioxide is the most commonly used pigment in the world and has been used for decades safely in thousands of products and articles due to its unique coloristic properties and the low toxicity. Epidemiological studies show no indications of problems in application practice
The proposed classification would not lead to an improvement in health and environmental protec-tion, because there is no hazard of relevance: high dust concentrations are only expected in the working environment, which are in Germany as well as most other European countries already cov-ered by strict occupational exposure limits. As the expert panel of CARACAL noted, the risk to consumers is negligible as the high exposure level required to observe an effect is unrealistic under normal conditions. Contact with skin or oral intake poses no danger, as the RAC determined in their assessment.
From our viewpoint, the current proposal for the CLH entry of titanium dioxide – which is written in a very complex wording (entry for TiO2 in powder with two notes and additional labelling
requirements for liquid and solid mixtures) – impressively demonstrates that the CLP Regulation is obviously not intended and unsuitable to regulate particle effects. It is essential not to include titanium dioxide in the 14th ATP, as has been proposed by the German public authorities too. Instead, initially an overall concept should be developed for the safe handling of PSLT dusts and the issue should be considered under occupational health and safety.
Read full responseResponse to Amendments of the Annexes to REACH for registration of nanomaterials
3 Nov 2017
VdMi (German association of producers of pigments and fillers etc) feedback on the Amendments of the Annexes to REACH for registration of nanomaterials:
Due to the fact that the EU definition covers almost all poorly soluble substances (inorganic and organic), most pigments and fillers could be considered nanomaterials. Because of the particularly strong impacts on the pigments and fillers industry, we would like to submit a statement of our own. In addition we would like to mention that there are still a lot of uncertainties regarding nanomaterials because the review of the definition is not finalized yet. Closely linked to that and in spite of the NanoDefine project being finalized soon there are still no universally accepted methods for making the decision whether a material is a nanomaterial or not. Furthermore we would like to highlight our concerns regarding the proposed timeline for the implementation of the nanospecific requirements according to the draft proposal. This holds true especially with regard to the upcoming registration deadline for tier 3 registration June 2018 and the extremely high workload for industry. In addition we would like to stress that most of the pigments and fillers are phase-in substances which are on the market since long and for which data have been generated in the past. For animal welfare and efficiency reasons it is important that priority will be given to the use of existing data instead of generating new data.
Pigments and fillers are used for the colouring and surface structuring of nearly all products found in our daily life. They consist of small particles which are insoluble and firmly bound in the application medium (e. g. paints, coatings and plastics).
Pigments and fillers have been used for centuries and they are the results of industrial research from the past one hundred years.
In Europe, around 100 companies are engaged in the synthetic manufacture of pigments and fillers (ca. 75% of these are small and medium-sized enterprises). These businesses combined achieve sales of roughly 8.1 billion euros and employ around 23,000 staff. Europe accounts for approximately one third of the global market for pigments and fillers.
Characterization of nanomaterials:
Particle sizes of pigments and fillers (powder products) stretch for primary particles from some 10 nanometres to several micrometers. Additionally all powder products have the strong tendency to aggregate and agglomerate leading to particles sizes up to 100 micrometers. In special cases even primary particles may have dimensions of approximately 100 micrometers. Normally pigments and fillers have a broad particle size distribution comprising at least one order of magnitude.
The broad particle size distribution of pigments and fillers in combination with the limited availability of simple and easily accessible measurement techniques makes it difficult to distinguish between different nanoforms (chapter 2.4 of annex 6).
Information requirements in the supply chain must be workable:
The Commission’s demands to get information about nanoforms and their hypothetical changes during the application by downstream users are adding further difficulties and ambiguities. Not only is the application process in many cases inseparably linked with the incorporation of the particles in a matrix making the definition of a particle very difficult. Furthermore, most down-stream users will lack the detailed expertise about the particular behaviour of their highly variable raw materials (see recital 7).
No unjustified increase of the registration burden for companies:
A pragmatic approach is needed because of the fact that otherwise pigments and fillers and their downstream user products are no longer produced in the EU. Articles (e.g. printed articles, plastics materials) might be produced outside Europe as well.
Regarding concrete comments on the draft Regulation, VdMi supports the comments already submitted by Cefic.
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