Snail-pace regulation could Y
be a recipe for trouble
completion by the yearend and,
said Apostol...
continuing regulatory vacuum.
Perhaps the most significant de-
velopment is in Germany, where
new regulations relating t...
Tre| |eborg’s
hose products
are designed
to resist a
range of
of 3

Polycomp's drinking water compounds in the European Rubber Journal

An article about EU regulations covering rubber used in food-contact and drinking-water applications: 'Snail-pace regulation could be recipe for trouble...' Source:
Published on: Mar 4, 2016
Published in: Food      

Transcripts - Polycomp's drinking water compounds in the European Rubber Journal

  • 1. FOOD CONT TREGU TIONS Snail-pace regulation could Y be a recipe for trouble completion by the yearend and, said Apostola, "will offer the EC a chance to evaluate the results Development work continues amid slow progress towards EU controls over food-contact materials. Patrick Raleigh reports here is a surprising lack of urgency around the harmonisation of EU reg- ulations covering rubber used in food-contact and drinking-water applications — par- ticularly given the clear potential risks to human health in both of these areas. As well as the potential gaps in public safety, the lack of reg- ulation is creating inefficiencies throughout the supply chain — rubber components manufactur- ers and their customers report. Companies supplying pumps to the water industry, for example, report significant duplication of R&D effort as both they and rub- ber seals suppliers have to tailor their respective products to the specific requirements of different EU member states. European regulators have, so far, focussed their attention on EUROPEAN RUBBER IOURNAL 0 July/ August 2015 plastics materials in contact with food, according to Fazilet Ci- naralp, head of Brussels-based Eu- ropean Tyre and Rubber Manufac- turers Association (ETRMA). But, she commented: "There are no planned actions to harmonise the way in which rubber food contact materials are regulated. The Euro- pean Commission has not yet de- veloped a clear road map on how they intend to proceed. ” The Commission is studying the issue, according to Aikaterini Apostola, an EC spokeswoman on health and food safety issues. A study, she said, is being car- ried out by the EC's Joint Research Centre (IRC), and aims to provide a ”comprehensive description of the current situation concerning food-contact materials, for which there are no specific measures at EU level. ” The study is scheduled for and consider what, if any, possible steps need to be taken in the fu- ture concerning the regulation of food-contact materials in the EU. ” According to Apostola, a cen- tral issue for the Commission is to work out a definition for rubber materials under EU plastics regula- tions. Vulcanised rubbers, she said, are clearly beyond the scope of the plastics regulation, but many ther- moplastic elastomers, which are not vulcanised, will be included. As far as individual national leg- islations are concerned, she said that the EC had acknowledged independent moves to introduce standards by Germany and France and has confirmed that it would "consider" them if and when no- tified. But rather than wait for the EC to move forward on this front, several member states have moved to plug the gaps being left by the
  • 2. continuing regulatory vacuum. Perhaps the most significant de- velopment is in Germany, where new regulations relating to rub- ber materials used in Contact with both food and drinking water are due to come into force in 2016. These will restrict the rise of raw materials for the production of rubber articles used in these appli- cations to those on specific ‘posi- tive lists’, explains Helmut Hirsch of (ierman rubber industry asso- ciation the WDK (Wirtschaftsver— band der deutschen l<autschukin- dustrie eV). A positive list for articles coming into contact with drinking water was prepared years ago under the charge of (}ermany’s Federal Envi- ronment Agency (Umweltbundes- amt, UBA). Phase-out By the end of 2016, said Hirsch, the current list will be phased out and replaced by a new list ”creat- ed using a fundamentally different way to determine the suitability of substances for use in articles in contact with drinking water. ” The requirements concerning articles in contact with drink- ing water are "in the lead” of the UBA and detailed in its Elastomer- leitlinie guideline document, the WI)K leader pointed out. From 1 Jan 2017, rubber chem- icals will require approval with their properties and migration behaviour to be presented to the authorisation body. This, noted Hirsch, is ”a ti1ne—consuming and cost-driving process. ” The food-contact requirements are laid down in the Federal Insti- tute for Risk Assessment (Bundesa— mt fur Risikobewertung, BfR) rec- ommendation XXI for materials in contact with foodstuff. This is an extension of the pos- itive list on monomers and ad- ditives — part of the Regulation 10/2011/EC on plastics materials intended to come into contact with food. According to Hirsch, substance manufacturers and importers will be responsible for entering the authorisation process — similar to the registration process for the EU chemicals regulation REACH. Asked how prepared companies are to meet the regulations, Hirsch said: ”ln most cases they are well prepared” as they had relevant data from previous registration processes. Unlike REACH, however, only one applicant is required to under- take the authorisation process for a substance. This, said the WDK leader, means that "all other play- ers in the market will benefit from it. That makes raw material suppli- ers rather reluctant in taking the initiative. ” Another departure from REACH is that rubber article manufactur- ers can also go for an authorisa- tion. “That is exactly what some WDK member companies are cur- rently doing, ” Hirsch reported. “In a WDK-co-ordinated project the data-collection and application ‘ In the food and pharma industries, requirements are increasingly stringent. ..reliability is sometimes, literally, vital ’ ROBERT UNEKEN FOOD CONTACT REG U LATIONS for authorisation for some crucial substances is going to be prepared. But with much of the work still to be done and time running out, the WDK is urging companies, particular suppliers of rubber chemicals, to ”reconsider how to cope with the authorisation re- quirements in order to safeguard their business in foodstuff and drinking-water applications. ” Compounding Among the companies that are actively addressing these issues is Dutch rubber compounder Polycomp, which develops and produces food and pharmaceuti- cal grades based on FKM, FFKM, EPDM, and silicone. Vorden-based Polycomp regu- larly receives requests from the market to provide compounds that comply with the hygienic and toxicological requirements, according to the guidelines of the German Federal Environmen- tal Agency (Umweltbundesambt, UBA), as described in the Elasto- merleitlinie, said managing direc- tor Robert Uneken. In cooperation with these cus- tomers, over the past 18 months Polycomp has developed a range of compounds for drinking water applications that meet the new lilastomerleitinie, as well as W2 70, and WRAS for the UK market. The compound development work, said Uneken, started with the limited set of ingredients al- lowed under the Elastomerleitlin- ie, while also taking account of the various production technolo- gies used to manufacture seals and other rubber parts. "There are, for instance, obvi- ous differences between injection and compression moulding, ” ex- plained the Polycomp boss. ”A complicating factor is that the use of plasticisers and processing aids is hardly, if not at all, pos- sible when limits on microbi- al growth on non—metallic materials in contact with luly/ August 2015 0 EUROPEAN RUBBER JOURNAL In the dairy industry fat residues and chemicals can break down rubber materials 25 —
  • 3. 26 FOOD CONTACT REG U LATIONS Tre| |eborg’s hose products are designed to resist a range of challenging conditions drinking water have to be met [un- der W270]. ” The development finally result- ed in two different compounds with different cure speeds. Poly- comp, said Uneken, is targeting these compounds at applications including seals, pumps, valves and fittings for a range of sectors, in- cluding the food and pharmaceu- tical industries. '’In the food and pharma in- dustries, requirements are increas- ingly stringent and the reliability of the parts in the applications is sometimes literally vital, ” the managing director stated. Blackburn, UK-based Silicone Engineering supplies solid and sponge sheeting and extrusions such as tubes, cords and profiles for use in the dairy and food St beverage industries. It has around 130 employees, a turnover of £16 million (€22.5 million). Much of its products are sold to EU markets — Germany in particular. According to Simon Holmes, marketing manager, there is in- creasing market demand for sili- cone formulas that meet industry standards covering in applications such as food machinery, brewery tubes, food transfer tubes and bak- ing mats. ’’In the dairy market, for in- stance, chemicals have to be run through tubes to break down the fat residue and those chemicals can break down organic rubber easily, ” said Holmes. ”The same goes with heat — food industry needs a lot of heat and the amount of volatiles is a lot less in silicones, making them more heat-tolerable. ” Holmes is aware of the moves by the European Commission to assess the safety of food-contact rubber materials. However, he said, feedback from suppliers — mostly European — has indicated that his company's products will most likely be unaffected by any new regulation. Compliant He said all of Silicone Engineer- ing‘s general purpose (GP) solid silicone range is FDA-compliant, adding that the company also holds BfR (German food accredita- tion) and WRAS (water regulation) for its GP solid silicone materials. Among the company's recent de- velopments for the food industry is a solid silicone containing a silver ion additive that actively prevents the growth of harmful bacteria such as salmonella, E-Coli and MRSA. The anti-bacterial material, said Holmes, can be used, for example, as gaskets and seals in food pro- duction machinery, food/ beverage transfer tubes. It is also [used] as dairy tubing as it has been "inde- pendently proven to reduce milk bacto-scan results carried out on a dairy farm. ” Meanwhile, Silicone Engineering has also addressed issues around the additives used in silicone sponge, which conventionally make it diffi- cult to get products approved by the FDA for food contact. Selecting the right hose for ap- plications in the food & beverage Butyl rubber best for chewing gum Many brands of chewing gum use food-grade butyl rubber as the central gum base, which contributes the gum’s elasticity, according to supplier Lanxess. Because of its low permeability, flavour is retained longer than with natural rubber-based products and the transmission of air and wa- ter are minimised. low-temperature flexibility prevents it from becoming brittle and shattering, even in heavily-filled compounds. Because of its di- rect contact with human saliva, Lanxess says it applies the most stringent quality controls, consistent with food regulations and standards relevant to this application (e. g. FDA approved). Chewing gum made of butyl rub- ber also has a protective dental function and thus meets modern consum- er requirements particularly well. Another requirement is resistance to ageing which prevents hardening during shelf storage and thus helps to retain the soft texture required for stick gums. The chewing gum industry is the third most important market segment for Lanxess’ butyl rubber. EUROPEAN RUBBER IOURNAL I July/ August 2015 industry is a challenge in its own right, according to Olivier Libes, marketing & product develop- ment manager at the Trelleborg Industrial Solutions facility in Clermont-Ferrand, France. As well as hygiene, for example, fats and oils can cause a rubber compound to deteriorate, reducing the elasticity of a hose. The hoses must be able to withstand various cleaning processes, including the use of steam and chemicals such as nitric acid. If the hose handles dry material, like grain or sugar, it needs to be abrasion-resistant on the inside while abrasion—resistance on the outside is a requirement for outdoor applications. Alcohol production presents an- other set of challenges for hoses. For example, in some distillery applications alcohol stays in the hose for a period of time. ”One of the things about alcohol is that it tends to extract things from rubber compounds, so the alcohol may end up having a different taste, ” Dhiersat says. ”We’ve solved the problem with UPE, a polyethylene film inside the hose that prevents extraction. " Similarly, Libes explains, Trelle- borg is now working to improve the smell of its hoses. "Natural rubber has a very specific smell, ” he says. ”We use natural rubber because it is softer and more flexible than any synthetic rubber compound. But we are really looking to reduce that inner smell, which is especially im- portant to wine producers. ” Dhiersat adds, "We must meet stringent regulations in sourcing materials for our hoses, since they will be used in food applications. Regulations are getting more and more strict, so we must stay in- formed, and the choice of materi- als is becoming more limited. ”

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