Document MJ7mKMO00arp353dKyDEvwvrz
Jolien Pattyn
From: Sent: To: Cc: Subject:
Importance:
Jan Helskens a/June 2021 09:26
fecassociation.eu Wim De Veirman; Chris Phillips contact from the website
High
Dear Sir,
It is with a great surprise that I read your June edition of the FEC information letter (Nr. 20). I almost chocked on my coffee when I read the statements made in point 5: 'Progress on our PFAS activities'. Let me explain why I have a number of reasons to disagree.
The first one is very obvious. It seems that in the 'public discussion' we take a stand to defend PTFE as an essential use for cookware and housewares overall. I quote: 'The essential use concept is furthermore the subject of a position paper Eurofer is preparing with input from the FEC Senior Experts'.
To our knowledge to qualify as essential use you need at least 3 conditions to fulfil: 1. The material has no technical equivalent. 2. The material replacement is not economical viable to replace the existing solutions. 3. It must be scalable and available.
Not only is the consumer today offered two choices of product, one non-stick frypan with a PTFE offering and one with a ceramic technology but both can be bought at the same price. The products I mention are available (for example: more than 40% market share in Holland in 2020). Scalability is absolutely not an issue either.
To be clear: PTFE on housewares is a complete 'non-essential use'.
The second one is even more concerning. I quote again: 'It became clear that FEC as an organization needs laboratory data to be able to comment on legislative proposals and to take a strong position in the public discussion. However, the risks involved with making test results public have been brought to the table. It has been decided, that the test programs will be executed, but the results will be kept confidential within FEC'.
Hiding test results from the legislative proposals and public discussions? This path is not right at all. If you want a voice in a public debate about making our industry sustainable and future proof, you will need to come with solutions and not hide any kind of information whatsoever. Neither should FEC use the info as it is a spinning menu card.
As a company we cannot support in any way these ridiculous statements. We support that PTFE in housewares should be faded out in an ASAP-way. We don't support hiding relevant information in either way, good or bad. This information is in the interest of the public and the policy makers. The debate is the best for all stake holders: the public and the industry.
I read at the end of the paper that this was written with the support of people 'experts' who carry a company name. Chris Phillips under the cookware company resigns from the panel with immediate effect and the memberships of the Cookware Company and Thermolon are hereby terminated. We joined the FEC for a debate and we tried: reading this 'information letter' we failed. We will not be a cog in the machine that keeps PTFE in its current condition. And we will not sit by and look how we are supporting PTFE in houseware as 'essential' and use vital data 'after screening it' on the consequence of your business. Let's look at the facts of what they are as grown-ups. We are convinced our industry and our business is better off to work with the facts and not trying to create them. Because the information doesn't represent our views in any way we demand the following:
1. We want our 4 logo's removed from your website within 5 working days. 2. We want our remaining membership fee back. We don't support this direction at all. 3. Send this letter to all recipients of your FEC information letter. 4. Publish this letter in full on your website in 5 working days.
We don't want to be near the goals you have set as an organization. The correct reaction is to understand that this discussion is not just about profit but about the people you love. How much of your mess they will need to clean up, and their kids and so on... That idea translating is sustainable business. That is what the industry should do, not hide in anyway but lead the change.
Jan Helskens I Chairman The Cookware Company I www.cookware-co.com
HOUSE OF INNOVATION
ware .1Y
HK Office telephone: + 852 3151 7508 HK Mobile: + 852 6133 8445 BE Office telephone: + 32 9 325 78 60 BE Mobile: + 32 495 54 65 23 MilMsAcookware-co.com
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On 5 March, the European Commission announced, the EU had agreed with the US a four-month suspension of tariffs related to the ongoing large civilian aircraft dispute. Negotiations have started between both sides to find a permanent solution, to avoid similar problems in the future and to include the digital service tax as well. However, four months is a very short period and it might be that the tariffs will be reintroduced. Although FEC members were not hit by these tariffs, we will continue to support coalitions against unrelated tariffs aiming at our industry. An update on the changes in May will be given in the next newsletter.
3. Tariffs Part II, CN - US On February 5, 2021, the US Court of International Trade took action on nearly 4,000 cases filed since September 2020 to challenge the Section 301 duties imposed on goods from China. If this case is successful, it is likely that importers that have filed their own lawsuits will recover the subject Section 301 duties for the relevant time period set forth by the litigation. If you imported goods from China to the United States and paid tariffs due to Section 301, please check whether you already joined the case. If not, you might still have time to file suit before August 20, 2021.
4. FIAC as new member of FEC We are happy to announce that as of February, 8 FIAC became a member of FEC. FIAC (Associazione fabbricanti italiani articoli per la casa, la tavola ed affini ) is the national Italian association and represents 19 companies operating in Italy. More detailed information can be found on their website ( https://www.aninia.itiassociazioni/elenco/fiac/). There are a number of interests in common and mutual opportunities. Via FEC, FIAC will get a much more direct contact to legal and political activities on European level. FIAC in turn has good connections to the national Italian authorities, especially to the 1SS ( L'lstituto superiore di sanita ). This enlarges the FEC network to the authorities. Our main contact person in the FIAC office is Alessandro Maggioni. Clemente Bugatti will join our Director Committee and Serena Pantano from the FIAC office will join our team of Senior Experts. Personal ties between FIAC and FEC have already been establish, which gives the prospect of an active and effective collaboration.
TECHNICAL NEWS
5. Progress of our PFAS activities
PFAS was and is the topic, which attracts most of the Senior Experts attention, because it became a major element in the New Green Deal of the European Commission. The group restriction proposal from five member states introduced the concept of essential use and the idea of restricting not only single substances but a whole class of substances. That's why PFAS is not only impact for those members dealing with non-stick coated cookware and bakeware. At the end it has a strong impact on the whole chemicals and food contact legislation.
Since the last General Assembly, a vivid discussion on our PFAS test programs took place within the DC. It became clear that FEC as an organization needs laboratory data to be able to comment on legislative proposals and to take a strong position in the public discussion. However, the risks involved with making test results public have been brought to the table. It has been decided, that the test programs will be executed, but the results will be kept confidential within FEC. Due to this important discussion the test programs have been delayed for several months. Now, after a consensus has been reached, they are starting.
Nevertheless, the Senior Experts have been active in contributing to the public discussion. Beginning of December 2020, we responded to the questionnaire distributed by the consulting firm 'Exponent' in relation to the group restriction proposal. In addition, we continuously follow the development at RIVM, the Netherland's authorities.
We reached out to the FluoroPolymerGroup (FPG), which is part of PlasticsEurope and support their activities to get Fluoropolymers as non-toxic substances out of the scope of the group restriction.
We created an article, summarizing our position on PFAS and PTFE, which has been published on Chemical Watch. With this article we reached a very large number of experts in the field of chemical and food contact legislation.
We participated in the preparation of the High Level Round Table. The European Commission called 32 stakeholders from industry, academia and NGOs to discuss the Sustainable Strategy for Chemicals. Among many other associations FEC is represented via CEFIC at this round table, where topics as the 'essential use concept' and the 'safe and sustainable by design' chemicals will be discussed.
The essential use concept is furthermore the subject of a position paper Eurofer is preparing with input from the FEC Senior Experts.
FEC c/o Unitam * 39/41, ru T. +33 (0) 1 47 17 64 60 * E.
ne -- F-92400 Courbevoie * fecassociation.eu * http://fecassociation.eu/ *
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6. FEC test recommendation for testing of coated articles
In reaction to the newest amendment of the EU plastic regulation the FEC Senior Expert team published recommendations for food contact compliance migration tests.
The EU plastic regulation 10/2011 is not foreseen or valid for organic coated metal kitchenware. Nevertheless, without a specific EU legislation on coatings it might be used for testing the overall migration limit (OML) and specific migration limits of organic substances of such coatings.
The newest amendment EU 1245/2020 implements a new demand for migration limit series. The migration results have to decline from the first to the second and the third migrate test.
This so-called stability demand of plastics cannot work for coatings, if the simulant corrodes and reacts with the metallic substrate of the coatings.
In such cases (as 3% acetic acid) either the stability demand should be excluded (for OML testing) or correct migration conditions should be taken (for the specific release limits of metals: Metal+Alloys Res (2013) 9).
The recommendations for migration testing of non-stick coated metal kitchenware have been published on time before the stability demand for plastics was enforced March 24, 2021 on our webpage and are thought for all food compliance stakeholders (companies, test laboratories, European lawmakers and their executing authorities).
The already known responses of nearly all big European food compliance test laboratories and of major retailers are affirmative.
7. 16th Amendment of Commission Regulation 10/2011 on Plastics in Preparation
The draft of the upcoming 16th amendment of Regulation (EU) 10/2011 was circulated to industry for consultation. The draft amendment contains significant modifications of the Regulation's text. It is expected that an official proposal for the amendment will be made available soon, most likely in the 2nd quarter of 2021. The most important changes are listed below:
a. The removal of several substances from the positive list of substances authorized for use in plastic food contact materials, i.e. untreated wood flour and fibers (FCM N 96), salicylic acid (FCM N 121) and lauric acid, vinyl ester (FCM N 436). The removal of FCM N 96 was justified by the need of addressing the use of bamboo or other wood, which were considered not in compliance with the Regulation due to the presence of ingredients, such as melamine and formaldehyde, above the permitted levels. FCM N 121 and FCM N 436 were removed because they have been identified by EFSA as substances that need re-evaluation, but data for such re-evaluation are currently missing.
b. Implementation of new specific migration limit (SML) for phthalates, five times lower than the previous limit, due to the introduction of a 20% factor accounting for exposure of population to phthalates caused by food contact materials, with respect to the total exposure.
c. Introduction of rules for the use of substances subject to the biocidal products Regulation (BPR). d. Rules for re-processing of offcuts and scrap materials from production. e. Permission to use substances manufactured through microbiological processes, without specific authorization. f. New labelling requirements for communicating restrictions on use of certain substances, including rules for
communication of these restrictions in case of repeated use food contact articles. g. Transitional measures allowing business operators to comply with the new requirements.
The draft in its current form has led members of the FEC Senior Expert Team to meet for consulting on the upcoming amendment, in order to comment on the most relevant points for FEC members. A feedback containing comments and suggested alternatives was forwarded on behalf of FEC to DGSANTE on March, 8. The Senior Experts Team focused on the points of major interest for FEC, as follows:
a. Clarifying the concept of "first placed on the market" introduced in the 15th amendment, in the newly proposed transition approach, the Commission identified that date as the date in which a declaration of compliance is issued for plastic materials and articles and products from intermediate stages of their manufacturing. Further, the amendment defines different timelines for intermediates, manufacturers and final materials and articles giving leeway to the supply chain to meet the targets required for compliance. The Senior Experts highlighted that separating the timelines does not serve the purpose of ensuring the fulfilment of compliance for final materials and articles due to the complexity of the supply chain. The urgent need for a transition period that would apply only to the final articles was suggested, in order to reduce complexly. The proposed amendment would also lead, among other things, to overlapping of the transitional periods of 15th and 16th amendments, thus increasing more complexity rather than decreasing.
b. Labelling requirements are introduced for substances for which indications in column 10 of Annex I of Regulation (EU) 10/2011 are established, that limit the use to a specific age, specific food (or group of foods), contact time or temperature, or heating conditions (e.g. oven or microwave use). These substances may be placed on the market only if labelled with instructions directed at the final user of the material or article. Such labelling shall be either displayed in accordance with Art. 15(7) of Regulation No 1935/2004 (the "glass and fork symbol") or, in case of articles for repeated use, indelibly affixed to the material by printing or embossing.
FEC c/o Unitam * 39/41, r
T. 4-33 (0) 1 47 17 64 60 *
lanc -- F-92400 Courbevoie * fecassociation.eu * http://fecassociation.eu/ *
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FEC stated that the proposed requirement for repeated use articles to bear indelible marking printed or embossed, is unnecessary and disproportionate. Especially when placing a product on the market in an EU country with a different language, the option of simply printing new packaging would not be possible in practice. This seems in particular a very heavy-handed measure for SME, which would lead to major investments in modification of production processes. The Senior Experts explained that self-explanatory symbols are not a straightforward solution, as long as they are not generally accepted or harmonized. Reference was made to the Framework Regulation, which gives manufacturer the option to such indications on the packaging respectively at point of sale.
8. SCIP database
The SCIP database (Substances of Concern In articles as such or in complex objects (Products)) is an electronic database of the European Chemicals Agency (ECHA) that contains information on substances of very high concern in articles or in complex objects (including Packaging).
Since January 5, 2021, EU suppliers of articles, i.e. producers or importers of articles, distributors or other actors in the supply chain placing articles on the market, are obliged to provide the European Chemicals Agency (ECHA) with information on articles containing substances on the REACH Candidate List (SVHC) above a threshold of 0.1% w/w.
The basis for the establishment of the SCIP database is Article 9 (1) (i) and (2) of the Waste Framework Directive (WFD - 2018) and Article 33 (1) of the REACH Regulation.
All EU economic operators supplying articles and components to another company/legal entity in the EU are therefore obliged to report relevant articles to ECHA in the SCIP database on their own responsibility. A SCIP notification number for the relevant articles/components is resulting.
For simplifying the notification process, SUP notification numbers and relevant data's from the suppliers can be taken over for complex articles and its components ("simplified notification" and "referencing"). Also "grouping" is suitable tool to simplify the notification.
Many states explicitly require filling with data from the SCIP database in the national implementation of the legal requirements, other states such as Germany do not for the time being! The national requirements for this are still pending!
Even if the necessary legal clarity is currently lacking nationally in some countries, it is to be expected that a concretization of legal requirements will follow to prescribes the filling of the database. Currently, more and more companies are requiring their suppliers to make entries in the database.
Where and how to make entries in the database? The start page for this is https://echa.europa.eu/de/scip
First of all, you must register as a user (if you have not already done so; via https://idp.echa.europa.eu/ui/createaccount) and then add the associated company (legal entity) in your own ECHA account. In the process, a tax number, for example, is also requested; however, the entry of a DUNS number is not a mandatory field.
There are three variantsfor data reporting
Entering the data offline (IUCLID software) or online (IUCLID cloud) using the IUCLID software or cloud provided by ECHA and then submitting the resulting and self-validated dossier to ECHA online via the "ECHA Submission Portal".
Or (possibly recommended for large amounts of data) data provision in a company's own IUCLID-compatible software and subsequent "system-to-system" transfer to the "ECHA Submission Portal". This poses great difficulties for companies in terms of operational implementation and technical support.
In case of data transmission in another form (letter, email), ECHA will reply with a standardized email. The manufacturers are requested to enter the data in the database and the allocation of SCIP No. is refused because the data cannot be processed.
Where can you find help on this? A first overview can be found here: https://echa.europa.eu/de/scip-suppliers-of-articles Below the six steps briefly explained there, you will find Questions and Answers in English. There are also videos on the use of IUCLID.
The 53-page manual in English also seems to be extensive here: https://echa.europa.eu/documents/10162/28213971/Information_requirements_for_scip_notifications_en.pdf/db2cf 898-5ee7-48fb-e5c8-4e6ce49ee9d2
In general, the input of the data is designed to be user-friendly and can be easily done with some practice.
Experiences and Difficulties
a. The biggest, most difficult and time-consuming factor for the companies concerned is the procurement of the relevant SVHC information from the supply chain and the creation of the lists with the required information for the SCIP database. The knowledge which SVHC substances are contained in articles at levels of 0.1% or higher is difficult to find out in the supply chain. The calculation of the SVHC content in the self-manufactured products and the constant updating of the SVHC candidate list also poses a great challenge for the companies concerned.
FEC c/o Unitam * 39/41, r T. +33 (0) 147 17 64 60 *
anc -- F-92400 Courbevoie * fecassociation.eu * http://fecassociation.eu/ *
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b. Prior to the SCIP database, companies were already required to proactively disclose levels of SVHCs above the threshold to supply chain participants and customers, but not to this level of detail. These required and relevant information are not matching the legal provisions in accordance with REACH (article 33). It is much more than that, ECHA requires e.g. TARIC-Number, primary article identifier, categories and subcategories of the complex article, starting point is the component containing the SVHC substance. Furthermore, the manual creating of the listed information for each article is very time-consuming and complex.
c. There are technical issues regarding the implementation "System-to-system" transfer to the "ECHA Submission Portal" for very large data volume! Even the IT experts in the companies' IT departments have to call on the support of external IT service providers who specialize in this interface issue. To find suitable solutions and competent support is also very time-consuming and costly.
d. Deleting incorrect or outdated entries from the database is not possible. However, existing data can be overwritten. This must be done in the same way as for an initial notification (via IUCLID and ECHA Portal submission). Access via the same ECHA account and use of the same "primary article identifier (type and value)" is necessary.
e. The companies are concerned regarding the confidential information about the articles provided to ECHA which maybe disclose to the competitors, consumer, relevant authorities and NGOs.
The aim of industry must be to reduce existing SVHC substances to a minimum. This is the goal of the European Chemicals Policy and this is the only way to escape the obligation to report.
9. Silver classification proposal from Sweden
Sweden led an evaluation of silver and its salts in the context of European regulation on biocidal products. At the end of December 2018, ECHA (European Chemicals Agency) has published the intention of the Swedish Chemicals Agency (KEMI) to classify silver nitrate as a category 1B reprotoxic substance. On July 2, 2019, ECHA published the intention of KEMI, as an extension of its work relating to silver nitrate, to classify metallic silver as well as other salts.
Concerning silver metal, the Swedish proposal is as follows:
skin sensitizer category 1, H317: may cause an allergic skin reaction; mutagen category 2, H341: suspected of causing genetic defects; reprotoxic category 1B, H360FD: may damage the unborn child; may damage fertility; dangerous for the aquatic environment: acute toxicity category 1; dangerous for the aquatic environment: chronic toxicity category 1.
This classification was proposed in the context of regulation on biocidal products, which does not directly concern silverware and tableware products. However, whatever the origin of the proposal, the classification of a substance by CLP Regulation (classification, labeling, packaging) may lead to the decision of a restriction of use or its introduction to authorization process under the REACH regulation. It can also have consequences on food contact materials regulation, by lowering the specific migration limit of silver in food, the limit value specified in the guide "Metals and alloys" published by the Council of Europe being already very low.
A public consultation on the silver metal classification proposal has been launched in October 2020 and ended on December 2020.
FEC has submitted a position paper to underline the followings points:
The silver classification proposal is based on studies carried out on silver nanoparticles and silver-containing active substances in the context of biocidal products regulation. No studies have been done on silver under massive form. The CLH report authors consider that nano-form and massive form have the same properties, particularly bioavailability, although they are totally different. Studies (not mentioned in the CLH report) have shown that only infinitesimal detectable amounts of silver are released from silverware and tableware articles under normal recommended use conditions. Moreover, this extrapolation from nano-form to massive form doesn't satisfy the article 9(5) of CLP which states that "the forms or physical states in which the substance is placed on the market and in which it can be reasonably be expected to be used should be considered when evaluating the available information for the purposes of classification"; - Considering FCM, the silver limit release value fixed by the guide "Metals and alloys" published by the Council of Europe has been established without existence of data on health risk of using silver in food contact materials; Manufacturing processes of silverware and tableware don't use and don't release in the environment silver powder or nanoparticles ; - Silver made articles are long lasting and carry a sentimental value; they are repaired and can be recycled indefinitely as well as scraps; Silverware and tableware are sold to consumers for several centuries without any evidence of skin sensitization, mutagenic or reprotoxic effects; In conclusion, FEC calls for a more realistic assessment to avoid placing unnecessary and unjustified burden on the silverware and tableware industries.
The Risk Assessment Committee (RAC) will have 18 months to provide its opinion to the European Commission For a final decision.
FEC 00 Unitam * 39/41, rue T. +33 (0) 147 17 64 60 * E.
anc -- F-92400 Courbevoie * c fecassociation.eu * http://fecassociation.eu/ *
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