test report re20339-2a migration test of … · 3% acetic acid 10 days at 50 °c / repeated use ......

Version RE20339-2A – this version replaces all previous versions This test report, including front-page and attachments, shall not be reproduced except in full, without written approval of Intertek Polychemlab B.V.

F 3.7-7 version August 2017 1 of 16

Intertek Polychemlab Koolwaterstofstraat 1 6161 RA Geleen The Netherlands Telephone: +31 (0)88 126 8888 Fax: +31 (0)88 126 8884 www.intertek.com

TEST REPORT – RE20339-2A MIGRATION TEST OF BLUE FOLDABLE CRATE

Requested by:

Euro Pool System International Attn. Mr. van Zuidam P.O. Box 1887 2280 DW Rijswijk Netherlands

February 13, 2018

RE20339-2A February 13, 2018



Version RE20339-2A – this version replaces all previous versions Revision: Inclusion of compliance check for Nickel SML in amendment Regulation (EU) 2017/752 based on

original results.

Dear Mr. Van Zuidam, Hereby we present to you the results of the laboratory study, which was carried out by your request (ref. SO20339). The general conditions of delivery of Intertek Polychemlab B.V., located in Geleen, the Netherlands, are applicable. These conditions are an integral part of all research carried out and the services and consultations provided; where appropriate, expanded upon by agreements specific to the client. This report applies only to the sample(s) tested. If information about the measurement uncertainty of a method is required, this can be provided on request. We trust that this information will meet your approval. Yours sincerely, Intertek Polychemlab B.V.

Job Ridderbecks Application Specialist Food Contact

RE20339-2A February 13, 2018



1 Samples

Date samples received

April 15, 2016 Description of samples

Table 1: Sample description

SAMPLE DESCRIPTION LIMS NUMBER

Blue foldable type 24 – sides (blue) Egyptene 6070 UA HDPE BASF 72-0575

22472872

Blue foldable type 24 – bottom (blue) Egyptene 6070 UA HDPE BASF 72-8225

22472873

2 Methods

2.1 Overall Migration testing (performed under SO16807, original report RE16807-4)

The overall migration test has been performed according to rules as laid down in Commission Regulation (EU) No 10/2011 (and amendments) relating to plastic materials and articles intended to come into contact with food. Test methods as described in:

• EN 1186-1; Guide to the selection of conditions and test methods for overall migration.

• EN 1186-2; Test methods for overall migration into olive oil by total immersion.

• EN 1186-3; Test methods for overall migration into aqueous food simulants by total immersion.

Simulants and test conditions are selected worst case for all types of food, even though intended use is for unpeeled fruit. To screen for specific migration of non-volatile substances, determination of an overall migration under test conditions at least as severe as specific migration conditions can be applied. This is described in Annex V , paragraph 2.2.1 of Commission Regulation (EU) No 10/2011.These results can be used to potentially exclude non-volatile specific migration components in future testing. Table 2: Test conditions overall migration / specific migration screening conditions

SIMULANTS TEST CONDITION*

3% acetic acid 10 days at 50 °C / Repeated use

10% ethanol 10 days at 50 °C / Repeated use

Olive oil 10 days at 50 °C / Repeated use

The tests with the aqueous simulants are performed in triplicate and the test with olive oil in quadruplicate. Overall migration limit is 10 mg/dm2 contact area.

RE20339-2A February 13, 2018



2.2 Heavy metals testing according to EU Directive 94/62/EC (performed under SO16807, original report RE16807-4)

Lead (Pb), Cadmium (Cd) and Chromium (Cr) by ICP-OES, after destruction of cryogenically grinded material specimen by in-house method. Mercury (Hg) by FIMS analyzer of cool cryogenically material specimen by in-house method. Chromium VI (Cr(VI)) by spectrometric analysis after extraction of cryogenically grinded material specimen by in house method (derived from EPA7196A) Lowest limit is < 100 mg/kg material.

2.3 Specific migration

Specific migration has been performed according as described in Commission Regulation (EU) No 10/2011 (and amendments) relating to plastic materials and articles intended to come into contact with food. Test methods are according to the relevant parts of EN13130 or on in-house methods. Simulant 3% acetic acid was selected as worst case for the specific migration substances that were tested. 10 days at 60°C was chosen as a worst case approach in relation to earlier tests performed at 50°C. A single use test was employed, as certain substances with an SML of 0.01 are required to be determined in the first run. As migration is expected to decrease with each run, testing as single use (equivalent to testing in the first run) was also used as worst case for the other substances.

SIMULANT TEST CONDITION

3% acetic acid 10 days at 60°C

Specific migration tests were performed on the following material. Specific migration limits are based on Commission Regulation (EU) 10/2011 for plastics or Chapter XI of the Dutch “Warenwetbesluit Verpakkingen en Gebruiksartikelen” for colorants and pigments.

MATERIAL COMPONENT SML

(mg/kg FOOD) METHOD

Egyptene 6070 UA (Blue foldable bottom, blue foldable sides)

Chimassorb 944 3 Excluded based on overall migration results, considering a reduction factor of 10 for unpeeled fruit and vegetables

BASF 72-8225 (Blue foldable bottom)

α-alkenes(C 20-C 24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6- tetramethylpiperidine

-

Carbon black -

RE20339-2A February 13, 2018



MATERIAL COMPONENT SML

(MG/KG FOOD) METHOD

BASF 72-0575 (Blue foldable sides)

1,1,1-trimethylolpropane 6 Excluded based on overall migration results, considering a reduction factor of 10 for unpeeled fruit and vegetables

Irganox 1076 6

Tinuvin 622 30

Chimassorb 944 3

BASF 72-8225 (Blue foldable bottom) BASF 72-0575 (Blue foldable sides)

Arsenic 0.01

ICP

Cadmium 0.01

Chromium 0.1

Lead 0.1

Nickel 1 / 0.02

Selenium 0.01

Mercury 0.005 Cold Vapour - AAS

PAA’s 0.01 LC-MS (Intertek Fürth)

2.4 Visual migration

Visual migration tests were performed according to Dutch National legislation – Warenwetbesluit verpakkingen en gebruiksartikelen, Chapter XI – Colorants and pigments, section 4b. Testing method, simulants and test conditions are used as described in Appendix part B, Chapter I, part 5.3.6 of this regulation.

SIMULANTS TEST CONDITIONS

3% acetic acid 5 hours at 40 °C

RE20339-2A February 13, 2018



3 Results

3.1 Overall migration (results from RE16807-4)

Sample: Blue foldable sides Contact area: 1.1 dm2 Volume simulant: 100 ml Table 3: Overall migration results Blue foldable sides

METHOD REPLICATES

MIGRATION INTO 3% ACETIC ACID

10 DAYS AT 50°C REPEATED USE

3RD RUN

(mg/dm2)

MIGRATION INTO 10% ETHANOL


3RD RUN

(mg/dm2)

MIGRATION INTO OLIVE OIL

10 DAYS AT 50°C REPEATED USE RUN 3 – RUN 2

(mg/dm2)

1 < 0.5 < 0.5 < 1

2 < 0.5 < 0.5 < 1

3 < 0.5 < 0.5 < 1

4 - - < 1

MEAN RESULT < 0.5 < 0.5 < 1

Sample: Blue foldable bottom Contact area: 1.2 dm2 Volume simulant: 100 ml Table 4: Overall migration results Blue foldable bottom

METHOD REPLICATES

MIGRATION INTO 3% ACETIC ACID


3RD RUN

(mg/dm2)

MIGRATION INTO 10% ETHANOL


3RD RUN

(mg/dm2)

MIGRATION INTO OLIVE OIL

10 DAYS AT 50°C REPEATED USE RUN 3 – RUN 2

(mg/dm2)

1 < 0.5 < 0.5 < 1

2 < 0.5 < 0.5 < 1

3 < 0.5 < 0.5 < 1

4 - - < 1

MEAN RESULT < 0.5 < 0.5 < 1

RE20339-2A February 13, 2018



Conclusion:

The overall migration results obtained of both samples were found to be in compliance with the restriction for the overall migration limit (< 10 mg/dm2) as defined in Commission Regulation (EU) No 10/2011 for food contact materials for the tests under the above mentioned test conditions.

3.2 Heavy metals testing according to EU Directive 94/62/EC (results from RE16807-2) Table 5: Heavy metals results

SAMPLE DESCRIPTION Cd

(mg/kg) Cr (total) (mg/kg)

Pb (mg/kg)

Hg (mg/kg)

Cr(VI) (mg/kg)

Blue foldable sides <10 <10 <10 <1 <2

Blue foldable bottom <10 <10 <10 <1 <2

Conclusion:

The results obtained of both samples were found to be in compliance for the heavy metals tests with the restriction of < 100 mg/kg material as defined in European Parliament and Council Directive 94/62/EC.

RE20339-2A February 13, 2018



3.3 Specific migration

Sample: Blue foldable (BASF 72-8225) (bottom) Contact area: 1.2 dm2 Volume simulant: 100 ml Results are expressed in mg/kg food, taking into account the conventional EU ratio of 6 dm² of surface area in contact with 1 kg of food. Table 6: Results obtained for the specific migration tests.

COMPONENT SML

(mg/kg)

SPECIFIC MIGRATION INTO 3% ACETIC ACID

(mg/kg)

Arsenicum 0.01

< 0.001 < 0.001 < 0.001

Mean: < 0.001

Cadmium 0.01

< 0.001 < 0.001 < 0.001

Mean: < 0.001

Chromium 0.1

< 0.01 < 0.01 < 0.01

Mean: < 0.01

Lead 0.1

< 0.01 < 0.01 < 0.01

Mean: < 0.01

Nickel 1

< 0.1 < 0.1 < 0.1

Mean: < 0.1

Selenium 0.01

< 0.001 < 0.001 < 0.001

Mean: < 0.001

Mercury 0.005

< 0.0005 < 0.0005 < 0.0005

Mean: < 0.0005

RE20339-2A February 13, 2018



COMPONENT SML

(mg/kg)


(mg/kg)

PAA’s 0.01

< 0.01

See Appendix I for full report FUFDCP2017-04065

Sample: Blue foldable (BASF 72-0575) (side panel) Contact area: 1.2 dm2 Volume simulant: 100 ml Results are expressed in mg/kg food, taking into account the conventional EU ratio of 6 dm² of surface area in contact with 1 kg of food. Table 7: Results obtained for the specific migration tests.

COMPONENT SML

(mg/kg)


(mg/kg)

Arsenicum 0.01

< 0.001 < 0.001 < 0.001

Mean: < 0.001

Cadmium 0.01

< 0.001 < 0.001 < 0.001

Mean: < 0.001

Chromium 0.1

< 0.01 < 0.01 < 0.01

Mean: < 0.01

Lead 0.1

0.10 < 0.01 < 0.01

Mean: < 0.10

Nickel 1

< 0.1 < 0.1 < 0.1

Mean: < 0.1

Selenium 0.01

< 0.001 < 0.001 < 0.001

Mean: < 0.001

RE20339-2A February 13, 2018



COMPONENT SML

(mg/kg)


(mg/kg)

Mercury 0.005

< 0.0005 < 0.0005 < 0.0005

Mean: < 0.0005

PAA’s 0.01

< 0.01

See Appendix I for full report FUFDCP2017-04065

3.3.1 Update February 13, 2018 – Nickel results

Results were originally reported with an LOQ of 10% of the then current SML for Nickel. As per Regulation 2017/752, the Plastics Regulation has introduced an SML for Nickel at 0.02 mg/kg food. Using the raw data for the Nickel analysis from this report, results can be re-verified against this new SML.

SAMPLE SML

(mg/kg)

NICKEL ANALYSIS RESULT (µg/L SIMULANT)

NICKEL MIGRATION RESULT

(mg/kg FOOD)

Blue foldable sides 0.02

0.5 0.2 0.3

Mean: 0.3

0.0003 0.0001 0.0002

Mean: 0.0002

Blue foldable bottom

0.5 1.0

< 0.1 Mean: 0.5

0.0003 0.0006

< 0.0001 Mean: 0.0003

Conclusion

The specific migration results of all components obtained for both samples were found to be in compliance with the restriction for the specific migration limits as defined in the Dutch Warenwetbesluit verpakkingen en gebruiksartikelen, Chapter XI – Colorants and pigments. Update February 13, 2018: The specific migration result for Nickel was found to be below the SML for Nickel laid down in Regulation (EU) 10/2011, as amended by Regulation (EU) 2017/752.

RE20339-2A February 13, 2018



3.4 Visual migration

SAMPLE SIMULANT TEST CONDITIONS

MEASUREMENT 1

MEASUREMENT 2

Blue foldable sides

3% acetic acid 5 hours at 40 °C

No visual migration

No visual migration

Blue foldable bottom

No visual migration

No visual migration

Conclusion

The observed visual migration results are in compliance with the requirement of no visual migration laid down in the Dutch Warenwetbesluit verpakkingen en gebruiksartikelen, Chapter XI – Colorants and pigments, section 4b.

RE20339-2A February 13, 2018



Appendix I - Report FUFDCP2017-04065

RE20339-2A February 13, 2018



test report re20339-2a migration test of … · 3% acetic acid 10 days at 50 °c / repeated use ......

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