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FOOD CONTACT RUBBER COMPOUNDS
Luis TormentoFebruary/2016
Introduction
• The objective of this presentation is to give a briefly description of:– The legislation about the use of rubber in
contact with food.– Both in US / Europe.
• Implications.• Challenges for the future.
American Legislation - FDA• In the US the Food and Drug Administration (FDA) consider three types of
nourishment additives:– Direct nourishment additives - Components added to the food, as part of a
treatment process or, as the extraction process.– Indirect nourishment additive – substances that can be enter in direct contact with
the food, but is not designated as a direct component of the food (package / equipment, process, etc.)
• The federal code 21 CFR 177 – cover polymers as «indirect nourishment additives".
• Specific legislation FDA for rubber is CFR 21 FDA 177.2600, “rubber artifacts for repeated contat use with food”.
• If the product is designated for the American market, and will be in contact with food, it must comply with this legislation.
• Other countries usually use this rules, too.
FDA Legislation 21 CFR 177.2600• Recognize specific types of foods (fatty/aqueous based)• Have a list of allowed materials, with safeguards about this utilization.• Essentially a list of allowed bases: “elastomers”, “vulcanization materials", "accelerator", "retarders",
"activators", "antioxidants", "plasticizers", " fillers” , “colorants”, “emulsifiers” and other additives.• Main advertences of use:
– Accelerators <1,5%– Activators <5%– Retarders <10%– Antioxidants <5%– Plasticizers <30%– Chanel or furnace carbon black <50% (without milk / contact with foodstuff oil)– Carbon black level<10% in contact with food based on foodstuff oil or milk.
• Projecting a compound for contact with foodstuff oil/milk could be a difficult task – due to limits imposed for carbon black levels.
• The significance of this is that other filler types, like silica must be used – and this could be a problem.
FDA Legislation 21 CFR 177.2600• Listed ingredients on the regulation 177.2600 (c4) can be used – since
they comply with the rules and requirements set out on sections 174-178, and 179,45.
• Ingredients / materials not mentioned on 177.2600 (c4) also cam be used.• Recognize that some materials are inherently safe, those are classified as
"GRAS", "generally recognize as safe".• Sensible approach, extending the field of view in the rubber composition.
– Examples of GRAS materials are: calcium stearate, rapeseed oil...• Substances can be used after prior sanction or approval.• Substances included on parts 170 - 189 do CFR 21 can also be used in
rubber products, subject to the provisions of the regulations.
FDA Legislation 21 CFR 177.2600• Product extraction limits (per product unit SA) in spite of every food type.
– Greasy food – n-hexane – extract limit (mg / square inch)• 20 milligrams / square inch - 1º - 7 hours• 1 milligram / square inch - 2 following hours.
– aqueous food - water extract• 175 milligrams / square inch - 1º - 7 hours • 4 milligrams / square inch - 2 following hours.
• It is possible to project a formula with the composition rules – that not fulfil the extraction requirements.
• 177.2600 also requires that rubber products are thoroughly cleaned before the first use.
FDA Legislation 21 CFR 177.2600
• very sensible approach• The list must be updated!• Asbestos, and β-naftilamine are included, so
the supplier for food contact rubber product must be aware!
American Legislation - FDA
• The reviewed and updated edition of the Code of Federal Regulations (CFR) 21 are edited in the month of April each year.
• On-line access is: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=d36753bca57802e9889f3bc4f277c77e&rgn=div5&view=text&node=21:3.0.1.1.8&idno=21#21:3.0.1.1.8.3.1.21
European Legislation• We have in Europe two types of legislations:
– UE Directives – implemented by the state member.– UE Regulations – implemented by UE.
• Regulation 1935/2004 exists and is applied to rubber. Stablish general regulations for all materials in contact with food.
• The fundamental principle of this legislation is that all material in contact with food, must not transfer their constituents to food in a way that could endanger the health, change the composition of food, or cause a deterioration in the organoleptic properties..– Note - organoleptic = sensory properties, smell, taste, color, texture,
etc. ...– Must comply 1935/2004, if it will be supplied to the European market.
EU Legislation 1935/2004• Other important points:
– Must meet special requirements for specific materials numbered in Annex 1 (e.g., rubber, wood, etc.).
– Must comply with the requirements for active materials - added to change the food in a positive manner.
– It describes an authorization procedure for food contact - materials / ingredients.
– Labelling requirements - instructions should be given the desired application / safe use, wine glass / fork symbol.
– Need of a "declaration of conformity" (with specific standards for each type of material).
– clear traceability rules (critical because of potential situations of recall).
BfR Recommendation 21
• The main objective of the German Institute BfR is working to make an important contribution to safety in foods, substances and products become safer.
• The recommendation BfR XXI cover natural & synthetic rubbers.
• Separate guidelines are in place for other materials in contact with food, for example silicone rubber (XV), or polyethylene (III).
• These are recommendations, not laws.
BfR Recommendation 21 Strict analysis limits of product migration are in place. For the category 3:
Zinc limit content / lead content N-nitrosamine extraction Amine extraction ZDBC extraction
approved laboratories must carry out the tests on products to demonstrate compliance with formulation.
It is usually requested a copy of the formulation - for verification / audit. Laboratories will also request statements of the ingredients used in the formulation in
contact with food. RAL (German Institute for quality assurance / certification) can certify compliance. Show the symbol knife / fork on the product.
BfR Recommendation 21• They are occurring new procedures for the introduction of other
ingredients.• New ingredients can be proposed.• Should be very clear any 'advertisement' against any BfR
recommendation.– For example, a recent advertisement from the recommendation 21 has
changed the test procedure for product extraction and for its execution.• These are published in the 'Bundesgesundheitsblatt' (German
Journal of Health Sciences)• Be careful - It is possible to develop a formulation that meets the
requirements of BFR, but did not meet the extraction requirements!
REACH• Major challenge in Europe in the future is the REACH (European
Regulation EC 1907/2006).• Documentation with 800+ Pages• Deals with the Registration, Evaluation, Authorization and
Restriction of Chemicals.• It entered into force on 1 June 2007.• Main objectives are:
– Improve protection of human health and the environment from the risks that can be posed by chemicals
– Increase the competitiveness of the EU chemicals industry.– Promote alternative methods for assessing the hazards of substances– Sharing chemical safety information.
REACH• All data on chemicals stored by the European Chemicals Agency (ECHA), which
will also run the evaluation process.• All manufacturers or importers of chemicals must have a register of it, to
commercialize on EU.• "Phase 1" substances - were manufactured or imported before REACH enters into
force. These had to be pre-registered before 1 December 2008..• 30/11/10 - It was the first deadline for registration for phase substances.
– From this date, it will be against the law to manufacture or import any non-registered substances covered by this term
– Substances manufactured or imported to 1,000 tones per year or more– Carcinogenic, mutagenic or toxic to reproduction - 1Q substances above a
year.– Hazardous substances liberated to the environment in excess of 100 tons per
year.
REACH• 05/31/13 - It was the next application deadline - for substances manufactured or
imported in 100-1000T per year.• 05.31.18 - Registration deadline for substances manufactured or imported in 1-
100T per year.• Some chemicals will not be registered - where the level of current use does not
justify the costs of registration.• Some chemicals are becoming not available for use in Europe.
REACH – Future Demands• According to the REACH - The use of some chemicals is already restricted. For example,
phthalates are not allowed for use in soft toys for children. (Annex 17 - Restrictions).• List of major concern (SVHC) has been produced and is being increased.• SVHC list highlights materials where the current restrictions may not be suitable.• Phthalate plasticizers are on that list, including DOP and DBP.• The use of these will become more restricted, for example the use of DOP is subjected to
authorization.• The use of DOP after 02/21/15 "expiration date" will be prohibited, unless the use is
authorized.• These materials are both BfR / FDA approved listings as approved plasticizers.
Food Contact – Future Demands• Market volatile materials:
– It can be difficult to approval of materials in contact with food.– Raw material for local production will change in a short term.
• Change the process of materials in contact with food must be managed in a professional and controlled manner.
• Some limits of extraction now are parts per billion.• Currently - near the analytical detection limit, questions of repeatability test are in
discution.• The development of analytical technology .... And the latest techniques means that the
extraction limits may fall further.• Contact formulations with food, with a long history of use could suddenly no longer meets
the extraction requirements or become obsolete or restricted because of the implications of REACH.
• In addition the EU legislation governing the use of rubber in contact with food must be changed.
Contact
LT QuimicosAv. Pedro Severino Jr., 366 Cjto 35
04310-060 – São Paulo – SP – BrasilLuis TormentoNPD Director
[email protected]: +55 (11) 5581-0708
