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.

1. FOOD CONTACT RUBBER
COMPOUNDS
Luis Tormento
February/2016

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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!

8. 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=d36753bca57802e9889f3bc4
f277c77e&rgn=div5&view=text&node=21:3.0
.1.1.8&idno=21#21:3.0.1.1.8.3.1.21

9. 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.

10. 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).

11. 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.

12. 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.

13. 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!

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. Contact
LT Quimicos
Av. Pedro Severino Jr., 366 Cjto 35
04310-060 – São Paulo – SP – Brasil
Luis Tormento
NPD Director
Luis.tormento@ltquimicos.com.br
Tel: +55 (11) 5581-0708