Regulatory compliance & food safety

Mike Simoni

8 October 2018
Food safe packaging

• Sun Chemical has both presentations and training

courses covering current FCM regulations. Due to
time constraints these will not be covered in this
presentation.
• Instead we will focus on:
1. How we communicate regulatory information along
the supply chain.
2. What new things are happening for regulatory
compliance.
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 Information flow
• xx
Information flow in the supply chain – our customers

• For Food Contact Materials (like food packaging) Brand Owners require our
customers to provide them with a Declaration of Compliance (DoC).
• The primary responsibility is with the packaging creator.
• The DoC information regulatory requirements
do not require a high level of detail.
• However an EU Member State enforcement via DoC form
authority can request the information that the
Converters Brand Owners
converters used in order to create their DoC
(in case of problems).
• Many Brand Owners also to audits of their suppliers (our customers) which
include looking at the information that was used to put together the DoC.

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Information flow in the supply chain – ink manufacturers
• Ink Manufacturers have a legal obligation to give our customers “adequate
information” to allow them to fill in their Declaration of Compliance (DoC).

via SoC form via DoC form

Ink manufacturers Converters Brand Owners

• Ink manufacturers in Europe have cooperated as a trade association called

“EuPIA” to agree what should be included in this “adequate information”, so
in theory a converter will get the same information no matter which ink
supplier he asks. EuPIA member companies pass on information about
potentially migrating substances that are in the printing ink / coating.
• We can choose not to pass on information about a substance but if it then
causes a compliance problem, we would have the legal liability. 5
Information flow in the supply chain – our suppliers
• In order to supply “adequate information” to our customers, we need to
know what substances are in our raw materials.

via RMF form via SoC form via DoC form

Raw material  Ink manufacturers Converters Brand Owners

suppliers

• We ask our raw material suppliers to fill out a detailed questionnaire, for
each raw material. If the questionnaire is not filled out then the raw
material cannot be SAP Coded.
• Our suppliers have a responsibility to give us accurate information.
• We sometimes do analytical testing to confirm their data, but we would
prefer not to do unnecessary re-testing.
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How to know what substances to look for – the Statement of Composition
• Substance (with the potential to migrate).
We include extra information about the substance such as CAS No. and where
present Food Contact Material No. and Plastic Material No.
• How much of it is allowed to migrate into food (SML)
Sources of the SML may be the Plastics Regulation, the Swiss Ordinance lists, an
EFSA opinion or another recognised source. SML’s are measured in mg
substance migrating into Kg food. The highest allowed (global) migration limit is
60 mg/Kg.
• How much substance will be in the food, making some assumptions
and doing a worst case calculation where 100% of the substance migrates.
The assumptions are the amount of the sold component in the finished ink, the
amount of coating weight the customer will apply, the area covered by the ink,
how well the customer will dry the ink and what the
surface area of packaging and weight of food will be.

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What a converter should do with the
Statement of Composition
• The SoC makes assumptions because
there is information about the printed
package that we do not know at the time
when we are supplying the ink.
• In cases where substance concentrations
change as part of the curing / drying
process the converter may need to do a
test (example: solvent retention).
• The converter can then use this
information to do their compliance
assessment.

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Compliance with the Framework Regulation
• The final compliance is with the 1935/2004 Framework regulation. Substances
should not migrate at levels that could endanger human health.

• The Framework Regulation does not distinguish between Intentionally Added and
Non-Intentionally-Added-Substances (NIAS) and so both need to be considered.

• Regulatory communication along the supply chain should be good enough that the
final FCM creator can certify compliance.

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 Direct Food Contact
• xx
Direct Food Contact
• When an ink or coating is in Direct Contact with food (touching the food)
then there are additional measures that we should put into place. This is
because the very short diffusion path between ink and food makes
migration more likely (there is a greater potential risk).
• We need to have additional scrutiny on or choice of raw materials, and on
the purity profile of these raw materials. This additional scrutiny is likely to
involve analytical testing, and an extended dialogue with our raw material
supplier.
• We need to have additional measures in place to minimise the potential for
contamination during the production process. This could involve very
thorough clean-downs of equipment (with the cleaning process validated
by analytical testing), but some cases the clean down is so labour intensive
that it is easier to have dedicated equipment.

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Direct Food Contact
• Sun Chemical is not in a position to dictate which applications do or do not
use Direct Food Contact inks. When we are advised that a customer
requires a DFC ink / coating for a particular application then we will
develop and supply a suitable product.
• We would suggest that our customers discuss the requirements with their
customer. We do have a good understanding of the regulatory
requirements and would be happy to give advice.
– The wording of the regulations is about intended or foreseeable use.
• Along with the product we supply a Statement of Composition, the
disclosure rules that we use for DFC inks/coatings are different and we
disclose a greater number of substances.

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Other sources of risk, and the need for GMP

• Many ink trade associations have created Good

Manufacturing guides that when followed will
ensure compliance for their members.
– EuPIA (European Printing Ink Trade Association) updated its GMP
policy on 31st March 2016. The updated GMP policy gives a much
more detailed guide on what is required for compliance, in order to
create a level regulatory playing field in the ink / coating industry.
• Sun Chemical globally implemented a GMP policy
in response to the EuPIA initiative.
– The Sun Chemical GMP policy uses FMEA based risk assessment
along with self assessment questionnaires to assess compliance. It
uses a process of continuous improvement to ensure that we
continue to improve.

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Other sources of risk, and the need for GMP

• The aim of our GMP is to provide our customer with an ink and the
container it is in (primary packaging) that is ………….

Free from Biological contamination (Hygienic)

Free from Physical contamination (Safe)

Free from Chemical contamination (Compliant)

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 Future regulation
• xx
Future regulations - German Ink Ordinance & EU measure on pFCM

• On 5th July 2016, Germany notified to the European Commission the draft of the 21st
ordinance amending the German Consumer Goods Ordinance (21. Verordnung zur Änderung der
Bedarfsgegenständeverordnung) pursuant to Directive 98/34/EC; this amendment is called “Printing Ink Ordinance”
(“Druckfarbenverordnung“).
• During the standstill period, which expired on 6th October 2016, eight EU Member States
had expressed their concerns by “detailed opinions”.
• This resulted in the EU Commission deciding to create a measure (regulation) for printed
Food Contact Material (pFCM). We believe that this will cover the printing ink layer in a
pFCM. The timetable was originally to have this measure ready to implement by end
2018.
• All of the trade associations involved in printed Food Contact Materials have come
together under the banner of the Packaing Ink Joint Industry Taskforce (PIJITF) to create
an industry view of what future EU regulation should look like.
• As a result of this EU Commission activity the German Authorities have halted their work
on the GIO, but reserve the right to restart the activity if the European measure does not
progress.
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 Future regulations - EU measure on pFCM

• We now have a position paper where 16 trade

associations involved in the pFCM value chain
have agreed a common position.
• Work continues within the PIJITF to fine-tune
the detail of the position, and to influence stake-
holders.

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Future regulations - German Ink Ordinance & EU measure on pFCM

• Meanwhile the EU Commission have decided that they want to do an Ex-

Post evaluation of the Framework regulation. This will be a fundamental
review of food contact material regulation in Europe, it will take at least two
years to do. The EU Commission do not want to work on any specific
measures for non-harmonised FCM’s until they have completed the Ex-
Post evaluation of the Framework regulation.
• We are unclear how the German Authorities will react to this. They halted
their work on the GIO on the understanding that European regulation was
being developed.
• If the German Authorities do restart work on the GIO it is unclear to what
extent they would consider the detailed opinions of other EU member
states. It is also unclear whether they would consider any of the proposals
from the PIJITF position paper.
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Assessing safety for substance migration – Risk Assessment
• The EuPIA risk assessment process is based on EFSA methodology.
• If there is an existing Specific Migration Limit (SML) or
Tolerable Daily Intake (TDI) then we would use this.
• If there is available and relevant good quality
toxicological data, for example from the ECHA database
that gives NOAEL or DNEL limits then we would use this.
• In the absence of toxicological data and if TTC
methodology is suitable we would derive a Cramer Class
information using QSAR software (such as Toxtree).
• For Dietary Survey information we can use EFSA
consumption databases, along with a methodology
to establish concentration in food.
• We can do all of the exposure assessment using FACET.
(now available for download from JRC website)
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“Low Migration” and “migration compliant”.
• Historically the term “low migration” has been used to describe UV and offset inks
that were suitable for printing sensitive applications such as food packaging.
• However different companies had different interpretations of low migration, and
this has resulted in the term “low migration” becoming devalued.
• EuPIA decided that rather than try to resurrect “low migration” we would instead
focus on the term “migration compliant”. This is a much more meaningful term as
there are strict measureable specific migration limits that the printed ink layer
needs to adhere to.
• The term “low migration” continues to be used, but is now considered to be more
of a marketing term rather than something indicating fitness for purpose.

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Future regulations – Chinese FCM regulations
• The Chinese authorities are setting up a comprehensive set of FCM regulations

• A first draft for the adhesives commodity standard now

exists. The printing ink commodity standard is still under
discussion. Until this standard is published it is difficult to be
completely compliant with the Chinese FCM regulations.
• It is likely that the Chinese printing ink commodity
standard will be a negative list, but that there would
be a positive list for direct food contact inks.
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Hot Topics – Substance issues
• PAA’s from pigments - See Pigments in inks, FCM regulatory compliance poster.
• Bisphenol A - Used in many applications, including polycarbonate for infant feeding
bottles. Banned by the French government (and others), instead of setting a lower
allowed limit.
• Mineral Oils - Used in inks for newsprint, and can potentially be incorporated into
recycled paper fibres. Also many other potential sources. Main risk is from aromatic
fraction, and this is what may be controlled in a German Mineral Oil Ordinance.
• TiO2 – Will be classified as Cat 2 CMR based on rat dust inhalation study. Currently
unclear what the effects will be on downstream users.
• Solvents - In generating toxicological information for REACH registrations, a number
of solvents would now have enough data to have higher SML’s. Most relevant for slower
drying solvents used in flexo printing.
• Photoinitiators - Photo-initiators by their nature need to be reactive. Omnirad 369
(widely used in the industry) will be classified as Reprotoxic Cat 1B.

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The END

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