Intertek MSG Molecular Spectroscopy E216, Wilton Centre. Prepared by: Alan Forsyth Chemistry Laboratory

Transcription

1 Page I of 6 Report No. CHEMIST/W000424RLOO I lntertek Intertek MSG Molecular Spectroscopy E216, Wilton Centre Test Report: No. CHEMIST/W000424RL001 Rubber articles. Compliance with FDA 21 CFR , Bfr Empfehlung XV and Colour bleed test according to Bfr Empfehlung part B II. Date : 20/04/2010 I 0967 Prepared by: Alan Forsyth Chemistry Laboratory Work reported in this document, unless otherwise stated, was carried out under the terms of the UKAS accreditation for UK.AS Laboratory No Opinions and interpretations contained herein are outside

2 Page 2 of 6 Report No. CHEMIST/W000424RL001 TEST REPORT Rubber articles. Compliance with FDA 21 CFR , Bfr Empfehlung XV and Colour bleed test according to Bfr Empfehlung part B II. Report Number Chit Number Receipt Date Lab Book Reference File Reference Location Number of Samples CHEMIST/W000424RL001 ITWl /03/2010 CHEMIST/W E Description of Work Required BFR XV peroxide value, FDA 21 CFR repeat use. BFR colour bleed test Method Reference FDA 21 CFR , Bfr XV and MSG-LAB SOP-PML-1006 Samples Submitted Sample Identifier Sample Description Customer Identifier CHEMIST/W White rubber 7.5 kg reel 94541/01 CHEMIST/W Blue rubber 7.5 kg reel 92922/01 Blue sil 40 sil 70 CHEMIST/W Purple rubber sheets CHEMIST/W Red rubber sheets CHEMIST/W Orange rubber sheets CHEMIST/W Black rubber sheets CHEMIST/W Blue rubber sheets CHEMIST/W Brown rubber sheets CHEMIST/W Green rubber sheets CHEMIST/W Yellow rubber sheets CHEMIST/W Red/brown rubber sheets RESULTS FDA 21 CFR Rubber Article Intended for Repeat Use Work reported in this document, unless otherwise stated, was carried out under the terms of the UKAS accreditation for UKAS Laboratory No Opinions and interpretations contained herei n are outside

3 Rubber articles intended for repeat use in contact with aqueous foods. Distilled water at reflux temperature 7 hours followed by 2 hours Page 3 of 6 Repo1t No. CHEMIST/W000424RLOO I 1st Extraction distilled water Table nd Extraction distilled water Table st Extraction distilled water Table /01 sil nd Extraction distilled water Table 4 Sample Result m/inch 2 Mean m/inch 2 FDA limit m/inch /01 sii Rubber articles intended for repeat use in contact with fatty foods. n- Hexane at reflux temperature 7 hours followed by 2 hours 1st Extraction hexane Table nd Extraction hexane Table Work rep01ted in thi s document, unless otherwise stated, was canied out under the tem1s of the UKAS accreditation for UKAS Laboratory No Opinions and interpretations contained herein are outside the scope of UKAS accreditation.

4 Page 4 of 6 Report No. CHEMIST/W000424RL001 1st Extraction hexane Table /01 sii nd Extraction hexane Table /01 sii Colour Bleed test conducted as per MSG-LAB-SOP-PML-1006 Table 9 water 10% v/v 3% w/v Sample aqueous ethanol aqueous acetic acid Arachis oil Purple N.D.B N.D.B N.D.B N.D.B Red N.D.B N.D.B N.D.B N.D.B Orange N.D.B N.D.B N.D.B N.D.B Black N.D.B N.D.B N.D.B N.D.B Blue N.D.B N.D.B N.D.B N.D.B Brown N.D.B N.D.B N.D.B N.D.B Green N.D.B N.D.B N.D.B N.D.B Yellow N.D.B N.D.B N.D.B N.D.B Red/Brown N.D.B N.D.B N.D.B N.D.B N/A = Not Applicable N.D.B = No Detectable Bleed Determination of the hydroxyl-peroxides as mentioned in the Bfr XV Silicone Ill 6 Work repo1ted in thi s document, unless otherwise stated, was canied out under the terms of the UKAS accreditation for UKAS Laboratory No Opinions and interpretations contained herein are outside the scope of UKAS accreditation.

5 Page 5 of 6 Repo1t No. CHEMIST/W000424RLOO I Method: 1 dm 2 taken for examination, cut into pieces of 2.5 cm x 1 cm. Surface area examined 2 dm 2 (both sides of the samples taken into account, because both sides are in contact with the reagents) Reagents added to the samples and placed for approx. 2 hours in a water bath at 70 C Measurement with spectrophotometer at 400 nm with a 4 cm cuvette. Calibration of H 20 2 with reagents Table 10 Sample Peroxide value Detection limit of Pass limit method 2 < 5 µg/dm 5 µg No positive reaction for peroxide Table 11 Sample Peroxide value Detection limit of Pass limit method 92922/01 sil 2 5 µg No positive reaction < 5 µg/dm for peroxide SUMMARY OF RESULTS FDA 21 CFR Rubber Article Intended for Repeat Use The samples: and 92922/01 sil 70 Blue meet the total extractive requirements of less than 175 mg/inch 2 for reflux at 7 hours and less than 4 mg/inch 2 for 2 hours at refux specified in the FDA 21 CFR Rubber Article Intended for Repeat Use for aqueous and fatty food contact. EUROPEAN COLOUR BLEED TESTS The samples submitted 29/3/2010 and described in Table 9 of this report pass the colour bleed test requirements of No Detectable Bleed based on of the specifications of the: German Bundesgesundheitsant (Bfr) Empfehlung IX of part B II The Netheralnds,'Verpakkingene-en-gerbruibsartikenbesluit ' of The Netherlands Werenwet Part B, Section 7. Belgium Moniteur Belg dated 24 September 1976 Section 3- Migration d' un colorant au pigment. Under the treaty of Rome the test covers all European Member States. Work repoited in this document, unless otherwise stated, was canied out under the tenns of the UKAS accreditation for UKAS Laboratory No Opinions and interpretations contained herein are outside

6 Page 6 of 6 Report No. CHEMIST/W000424RL001 German Bundesgesundheitsant (Bfr) Empfehlung XV Silicone Ill, 6 The samples: and 92922/01 sil 70 Blue comply with the meet requirements of German Bundesgesundheitsant (Bfr) Empfehlung XV Silicone I l l, 6 and that there was no positive reaction for peroxide. Report Authorisation SCIENTIST'S NAME Signature of Scientist David Eaves (Regulatory Consultant) /\ Date 21/04/2010 Work rep011ed in this document, u nless otherwise stated, was canied out under the tenns of the UKAS accreditation for UKAS Laboratory No Opinions and interpretations contai ned herein are outside