Establishing Fitness for Use in a Global Plastic Additives Business

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1 Establishing Fitness for Use in a Global Plastic Additives Business David Horst, Product Stewardship, BASF Corporation Anne Christian, Quality Management, BASF Corporation Dr. Tobias Eltze, Product Stewardship, BASF SE

2 Sensitive Applications for Plastic Additive Products Antioxidants Process stabilizers UV absorbers Light stabilizers Clarifying agents Nucleating agents Antistatic agents Slip agents Acid neutralizers Visbreakers

Food Regulation Compliance Compliance with food contact regulations involves 5 aspects: 1. Listing of the product on the positive list Declaration of Compliance 2.

3 Food Regulation Compliance Compliance with food contact regulations involves 5 aspects: 1. Listing of the product on the positive list Declaration of Compliance 2. Byproducts and residuals are controlled within safe levels 3. Degradation products from normal use must be assessed 4. Adequate control of product purity (major requirement for shared facilities) 5. Specific quality management system components

4 Definitions - GMP GMP: Good Manufacturing Practices As defined by specific regulations 21 CFR General provisions applicable to indirect food additives Good manufacturing practices [are] defined to include the following restrictions: Quantity limited by prescribed limits, technical effect in article, no intended effect in food Any substance used as a component of articles that contact food shall be of a purity suitable for its intended use Existence of a prescribed limit does not exclude from meeting other requirements Article 3 of EC Regulation 1935/2004 (The Framework Regulation) "Materials and articles... shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: Endanger human health or bring about an unacceptable change in the composition of the food or bring about a deterioration of the organoleptic characteristics thereof 4

5 Definitions - GMP GMP: Good Manufacturing Practices As defined by specific regulations Regulation (EC) 2023/2006 Good manufacturing practice (GMP) means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food Quality assurance system Management responsibility Adequate training Organization of premises Evaluation of starting materials SOPs enforced Quality Control system Monitoring of GMP attainment Corrective actions for failures Documentation Appropriate specifications, manufacturing and quality records relevant to compliance and safety of the finished material or article 5

6 Definitions Non-Intentionally Added Substance (NIAS) Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food Non-Intentionally Added They are exempted from the authorization and listing in Substance means an the Union list of (EC) 10/2011 impurity in the substances Any potential health risk in the final material or article arising from reaction and degradation products used or a reaction should be assessed by the manufacturer in intermediate formed during accordance with internationally recognized scientific the production process or a principles on risk assessment decomposition or reaction product 6

7 Definitions Fitness for Use Quality System Mgt. responsibility Management of Change CA & PA Traceability Quality risk analysis Product Listing Data generation Analytical work Migration testing Application areas Suitable Purity Market/ External Supply chain comm. Associations Degradation prods. Work w. Authorities NIAS Control Hazard assessment Exposure assessment Risk assessment Specifications 7

8 GMP in the Supply Chain Synthesis Blending Masterbatch/ Compounding Conversion End User Byproducts Specifications X-contamination Raw materials X-contamination Reaction prods X-contamination Reaction Prods Reaction prods 8

9 Non-Intentionally Added Substances (NIAS) Suppliers and Users do this NIAS Known "Listed" Known with toxicological data Known Without toxicological data Unknown SML 10/2011 Self derived TDI migration model/ TTC Migration < 10 ppb no CMR* *When migration < 10 ppb, no further considerations are necessary dependent on exclusion of CMR substances based on expert judgement.

10 Risk Assessment of NIAS Inventory Review or generate analytical work Compile existing risk assessments External information (supply chain, authorities, public) Assess Evaluation of migration into food Toxicological assessment of migrants Verify that there are no restrictions set by authorities Derive Tolerable Daily Intake (stdi) Threshold where applicable Conclude Tolerable migration into food File risk assessment Communicate resulting stdi to customers on Food Contact Certificate 10

11 NIAS Customer/ Brand owner perspective Users do migration testing for compliance purposes or for regulatory approvals Awareness of migrant identities and levels can be transferred up the supply chain. We can often help Migration estimate - Information to authorities Tox info - Tox work 11

12 Degradation/ Reaction products Additives producers within ELiSANA recently successfully concluded genotoxity testing of numerous reaction products (AKA Arvin substances) The drive was from the drinking water authorities ELiSANA Membership: Adeka Palmarole Addivant BASF Oxiris SI Group Songwon Arvin 8: 7,9-di-tert-butyl-1-oxaspiro(4,5)deca-6,9-diene-2,8-dione

13 Establishment of Suitable Purity Sites need this in order to be compliant What targets do we have to meet? We use the total migration calculation Uses SML (M) for contaminating substance/ product The maximum use level (X) of receiving subst. is also important EU authorities intend to change h from cm to 0.1 cm Plastic h 1 kg Food Y= allowable cross contamination into receiving blend A= 600 cm 2 /kg food Diffusion limits (based on LDPE) are used for high MW contaminants 13

AO blend? Stabilization with 1500 ppm (0.15%) Antioxidant blend 0.01x 10 5 = 121 ppm 600x0.1x. 92x0.

14 Food Exposure to Non- regulated Substance EU allows 10 ppb contamination of non- CMR w/o food approval (0.01 mg/kg food) ~ 875 cm 2 /kg food ~ 510 cm 2 /kg food How much of that industrial product could be allowed in an AO blend? Stabilization with 1500 ppm (0.15%) Antioxidant blend 0.01x 10 5 = 121 ppm 600x0.1x. 92x0.15 But the AO blend could be dosed at a higher concentration. If dosed at 5000 ppm, then 36 ppm cross contamination could be tolerated.

15 AO AcidNeut blend AO Blend 1 AO UVA blend AO Blend 3 AO Blend 2 AO-Hals blend 1 HALS1 Target examples Four Zones and marginal areas Zone 1 Sensitive into sensitive Numbers in cells represent the maximum cross contamination level in ppm of the substance in column A into the substance in Row 4 Max Concentration in plastic (ppm), Z Zone 2 Industrial into sensitive Max conc. for sensitive appl.(wt%) HALS NA AO-Hals blend NA AO UVA blend 3.12 NA AO Blend NA AO Blend NA AO AcidNeut blend 2717 NA AO Blend NA Zone 3 Industrial into Industrial Zone 4 Sensitive into Industrial 15

16 Challenges Business awareness? Capital projects coming? People Turnover? Inventory targets? Business management support? Understand? Changes? Regulatory mandates? Market requires? 16

17 Program approach Establish Team Partnership with Quality Mgt Strong Global collaboration Division of responsibilities Management commitment Business management Production management Product management Buy in Regional PMs Site quality Site mgt. Implementation Training Documentation Tools Audits 17

18 The Continuous Improvement Cycle Change & evolve Improve & learn Reduce waste & risk Act Plan Evaluate risk Preventative controls Targets Audit Analyze trends Measure Check Do Procedures Training Document 18

19 The Continuous Improvement Cycle Requirements Act Plan Check Do 19

20 Define the Requirements (X-C) Create matrix for each set of shared equipment Determine capability of cleaning method(s) Build clean-outs into the schedule Use chart for sequencing 20

21 The Continuous Improvement Cycle Requirements Act Plan Check Do Optimize sequencing 21

22 Smart scheduling Group products into families of related components/types Create schedule based on expected demand Resist schedule changes within frozen period Zone 2 Industrial into sensitive Happy balance of cleanout time, inventory, testing 22

23 The Continuous Improvement Cycle Requirements Act Plan Internal audit Check Do Optimize sequencing 23

24 Process Verification Is it done? Is it done well? Are all the required elements documented? Check metrics if applicable Focus on deviations and contradictions 24

25 Use non-traditional audits For-cause audits process review Exchange of knowledgeable folks as auditors Audit + consult + share + learn + improve 25

26 The Continuous Improvement Cycle Manage Change Requirements Act Plan Internal audit Check Do Optimize sequencing 26

27 Management of Change Engagement CCC System MOC Training Process 27

28 Steps in the MoC Process RECOGNIZE the change DEFINE the change, including objectives and benefits DISCUSS the change ANALYZE the change test, collect data, run scenarios, look at options and impact DECIDE to implement the change or not. If yes, IMPLEMENT DOCUMENT the change and COMMUNICATE the change CONFIRM the change, after-the-fact. Did it meet the objectives? 28

29 Examples of Change Triggers Products for Industrial Applications New hazardous ingredient or significant change in one Raw material changes that could change product identity New information/data from supplier Change of solvent or solvent make up Products for Sensitive Applications Any of the above Process change e.g. work-up, catalyst, change in impurity profile New chemical component or a significant change in one New supplier for raw material New supplier for blend component New product introduced into a shared facility Different raw material origin 29

30 Understanding Risks 30

31 Identify and Manage (Quality) Risk We use FMEA Annual RA required for processes handling sensitive applications Preventative controls are documented with risks Some risk categories are specified 31

32 Benefits of HACCP Certification/ Compliance Conduct risk assessment Identify control point(s) Establish control limits Monitor Correct Verify Document 32

33 Strategies for Meeting the Requirements Decisions influencing compliance What actions are possible? Risks/ benefits/ costs vs. other approaches Where are decisions taken? Capital project planning/ design Separate sensitive from industrial, design to minimize cross contamination Low risk lower chance of error. Higher initial cost Business leadership/ Operations Product Siting Separate sensitive from industrial where possible. Low risk lower chance of error. Possible impact on ongoing costs Business leadership/ PMs Scheduling e.g. Plan the product wheel to minimize situations where difficult cleanouts are required Higher risk of errors and NCMs. Higher operating costs, lower upfront costs Planners and site personnel Inventory Allowance of selective higher inventories can reduce stress on scheduling Reduce frequency of special cleanouts. Balance inventory costs against cleanouts and NCMs Planners and site personnel HACCP implementation Identify key risks to quality and address with action plan Can reduce risk and cost. Demonstrates compliance Planners and site personnel Operational methods Establish cleaning validations for various levels of cross contamination. Systematize cleanouts to reduce risk and cost Site personnel

34 Thank You! ερωτήσεις; Fragen? Preguntas? maswali? األسئلة Questions? प रशन? 問題嗎? 34

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