| United States | Canada | European Union | Latin America | Asia | Compostability and Biodegradability |
UNITED STATES
OVERVIEW
The regulation of Food Contact Packaging falls primarily under the jurisdiction of the FDA. Toy, Drug, and Cosmetic Packaging,
as well as Personal Care Packaging are regulated by the FDA and the Consumer Products Safety Commission. Recently the CPSC has
received enhanced jurisdiction under CPSIA HR4040, the US Consumer Products Safety Improvement Act, which places new accountability,
safety, record keeping, and third-party testing requirements on noted Consumer Products.
FOOD PACKAGING
TITLE 21: Refers to a list of regulations that relate to the composition of colors and additives used in food contact, drug packaging, etc.
They include general safety and purity requirements and limits of migration. Together, they form the basis for food contact notifications, Drug Master
Files and related requirements for record keeping and compliance. For example: If your product packages food, it must be FDA food-contact
compliant. The applicable regulations are: 21 CFR 177.1640, 21 CFR 178.2010 and 21 CFR 178.3297, and 21 CFR 177.1520.
HOUSEWARES EXEMPTION: This is a subjective, rather than objective interpretation of the law. The consensus states that if the plastic item only has momentary food contact, there is not enough time for anything to migrate to, or contaminate the food. If your product fits into this category you may be eligible for this classification, but all of the components of the product must be non-hazardous. Interestingly, as cup lids are not readily sold in stores, they are not allowed under the “housewares exemption”.
FOOD CONTACT NOTIFICATION (FCN): Manufacturers of colors and additives petition the FDA utilizing toxicology data, purity, conditions of use, human consumption factors, etc. for these approvals. FCN’s used to take up to 2-3 years they are now completed typically in 120-180 days. Products that receive an FCN typically have restrictions of use, such as application, level of content in the finished product etc. FCN’s usually require the help specialized firms in filling in the data and require substantial resources to initiate.
CONDITIONS OF USE: The FDA utilizes letters to define a condition of use, typically A-J. These letters refer to the temperatures the packaging will be subjected to as well as length, time, type of food substance and simulants to be used in migration testing. Conditions of use are used to develop the criteria used in migration testing of products.
THRESHOLD OF REGULATION: Existing products that are not specifically cleared through an FCN may be used under the “threshold of regulation”. If the product is demonstrated to be non-hazardous by the FDA under certain conditions and doesn’t migrate under its conditions of use it can then be used for food contact applications. Formulators use products that have been previously approved by the FDA wherever possible. It must be noted that any approval for use is limited by its condition of use, resin, and food type. For example: an approval for a colorant in General Purpose Polystyrene will not be valid for High Impact Polystyrene.
PHARMACEUTICAL PACKAGING
OVERVIEW
Pharmaceutical Packaging falls under both the FDA and CPSC. The FDA is interested in the composition of the product and CPSC is interested in the design of the package, such as child proof closures etc. The primary clause that most drug packagers adhere to is 21 CFR 211.94. This clause states that nothing must migrate out of the package that can potentially affect the purity or efficacy of the drug.
DEFINITION OF A DRUG: Any product that has any claim of efficacy is considered a “drug” by the FDA. This includes fluoride toothpaste,
Anti-dandruff shampoo etc.
DRUGS: Any product that is defined by the FDA as a “drug” (this includes GRASE OTC and Prescription as well) must be in compliance with
21 CFR 211.94, this applies to both the container and closure.
This Regulation states: (a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements. (b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. (c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
This can be interpreted as meaning that the package must not have anything migrate out of it into the product that can in any way alter or affect the safety or efficacy of the drug.
DRUG MASTER FILES: Drug Master Files are filed by the Drug Manufacturer and the package may or may not be included in the DMF. If it is included, then the DMF must be altered prior to allowing any change to the package components.
EXTRACTABLES AND LEACHABLES: Extractables and Leachables are potential contaminants that are perceived as potentially migratory in a pharmaceutical package. Examples of high potentials are: eye care saline solution, nose spray etc. Currently there are no FDA regulations regarding extractables or leachables unless they migrate in excess of a stated limit in a particular drug or food contact package. It is considered the responsibility of the package manufacturer to test for and self-certify for extractables and leachables.
PERSONAL CARE AND COSMETICS: These items are regulated by the FDA and Consumer Product Safety Commission (CPSC) in concert. The CPSC is concerned with the physical characteristics of the package e.g. child proof lids. The FDA is concerned with anything the can migrate out of the package into the product and adulterate it in any way.
The FDA has a “catchall” regulation for this - 21CFR 740.10. This regulation states: Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel: Warning -- The safety of this product has not been determined.
This regulation is a labeling regulation, it does not prohibit the use of any products in the container, however from a common sense standpoint it
makes sense to be in compliance.
OTHER US REGULATIONS AND CONCERNS
CONEG: (Coalition of Northeast Governors) The CONEG statute is designed to reduce the levels of four heavy metals (lead, cadmium, mercury, and hexavalent chromium) entering the waste stream by reducing the levels of the metals in packaging. This is accomplished through banning the addition of heavy metals to packaging materials, and imposing a 100 ppm limit on the incidental level of the metals in the packaging. It is important to note the CONEG prohibition against "intentional use." The intentional addition of one of the heavy metals in any quantity is not permitted.
PROPOSITION 65: This California State law, in practice, affects all packagers in the US. California has published a list of chemicals and updates it regularly with suspected carcinogens. If any of these chemicals are intentionally added to the product then a warning label must be placed on the product. It does not prohibit the use of the chemical, it merely has to be labeled as such.
CPSC & CPSIA HR4040: The law includes: new limits for lead in children’s products; a lower limit for lead in paint and surface coatings;
a ban on certain phthalates; mandatory third party testing; tracking labels and product registration cards; whistleblower protection; and increased
civil penalties. In particular it sets the following limits: Ban total lead in substrates to 600ppm. Prohibit phthalates, DEHP, DBP, or BBP not to
exceed 0.1%, Interim Prohibition - DINP, DIDP, or DnOP – not to exceed 0.1%. It must be stressed the testing to conform to HR4040 must be
carried out by Governmental accredited labs.
EU EN13427:2004: This is in fact a EU law, however it should be noted that many states are beginning to look at adopting regulations that follow this law. It primarily examines the full life cycle impact of a package including potential reuse, possible recyclability, the final waste stream impact, and supports the minimization of packaging.
THE QUANDRY OF “NON-REGULATION” REGULATIONS
How do you insure legality or acceptability of a package when no definite regulations exist? Unfortunately, no simple answer exists, because something that may be acceptable for food contact packaging (the most stringent in the US) may potentially have a skin contact or allergic reaction causing a bio-compatibility problem.
Currently, the only advice that can be proffered: if you want to insure that your package is safe, make sure that nothing will migrate from it! Resins have undergone rigorous testing to assure bio-compatibility and freedom from allergic reaction. So in theory, if nothing is going to migrate from the resin, there will not be a reaction. This is a practical approach, but keep in mind, it is impossible to certify a product to a regulatory standard that does not exist in the first place!
CANADA
FOOD CONTACT: Food contact products are evaluated on a case-by-case basis. Approvals of packaging materials are obtained through a letter of “no objection” which is issued by Health Canada. The letter is only needed if the food package is used during processing of the food product. Otherwise, the package must not contain anything hazardous, nor impart any taste or hazardous ingredients to the food under expected conditions of use. It must be noted that only the end-product receives an approval, individual components of the package are evaluated but do not receive approval. There is no defined list of approved (positive) additives at this writing.
COSMETICS AND PERSONAL CARE: If the product is considered either a personal care item or a cosmetic (essentially the same definition as in the US), then the package must not contain anything hazardous that may migrate out of the package into the finished product.
DRUGS: If the product is a drug, it falls under the Canadian Food and Drug Act. Then it is recommended that the food contact directives be followed. As there is no list of approved (positive) additives that can be used, if you want to have a drug approved the product must be submitted to Health Canada for a letter of no objection.
EUROPEAN UNION
OVERVIEW
Resin and additive use is controlled by the Plastics Directive, also known as the “Super Regulation” and other names. The Plastics Directive is a “Positives List” approving the use of named resins and processing additives used during the manufacture of the resins and compounded additives. The Plastics Directive specifically does not address Colorants.
A level of quasi-mutual recognition exists in the EU. Essentially if your product is cleared into an EU member country, it will likely be recognized by other EU member countries, however this is not a universal rule. France, in particular, does not recognize all other EU State clearances.
FOOD CONTACT REGULATIONS: In Germany the suitability of a food contact colorant is primarily determined by Plastics Directive, BfR EN 71 part 3 toy regulations and ISO 8124-3:1997. These regulations address the potential migration of antimony, arsenic, barium, cadmium, chromium, mercury, selenium, and aromatic amines.
In France the list of regulations includes:
MONOMERS DIRECTIVE 90/128/EEC, 89/108/EEC, PLASTICS DIRECTIVE 2002/72/EC
DECREE 73-128 OF FEBRUARY 12, 1973 AND RESULTING CIRCULAIRES
BANQUE DE DONNEES SPMP “LISTES POSITIVES MONOMERS ET ADDITIFS”
LISTE DES MONOMERES ET AUTRE SUBSTANCES DE DEPART AUTORISES SECTIONS A et B.
LISTES DES COLORANTES AUTORISEES IN FRANCE DANS LE MATIERES PLASTIQUES AU CONTACT DES ALIMENTS, LISTE
LISTE ADDITIONELLE D’ADDITIFS AUTORISES IN FRANCE.
LISTE DES ADDITIFIS AUTORISES EN FRANCE DANS LES MATERIERE PLASTIQUE AU CONTACT DES ALIMENTS-SECTION A
LISTE DES ADDITIFS VISESA L’ARTICLE 4, 3 EME PARAGRAPHE DE L’ARRETE DU 2/01/2003
French Directive 94/62/CE relates to Decree 98/638 requiring that products be free of heavy metals.
Decree 67/548/CE requires that the product contains no dangerous substances.
OTHER FOOD CONTACT REGULATIONS: There are a number of other regulations that supersede earlier ones and also are aimed at specific applications, they contain but are not limited to the following:
EC1935/2004
COMMISSION DIRECTIVE 2007/19/EC of 30 March 2007
89/109/EEC repealed by EC 1935/2004
COMMISSION DIRECTIVE of amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food
Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the
constituents of plastic materials and articles intended to come into contact with foodstuffs
TOYS, COSMETICS, PERSONAL CARE: For the most part, the EU Member States do not distinguish between food contact, toys, cosmetic and personal care items. If your product is a Toy, Cosmetic or Personal Care item, it must meet the food contact regulations. There are a few exceptions- however they must be addressed on a case-by-case basis.
OTHER EUROPEAN UNION COMMON REGULATIONS
RoHS: RoHS (Regulation on Hazardous Substances) Directive 2002/95/EC directs that there is no intentional addition of any of the following chemicals in a finished product: Lead (Pb), Mercury (Hg), Cadmium (Cd), Hexavalent Chromium (Cr (VI) ), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ethers (PBDE).
WEEE Directive 2002/96/EC and 2003/108/EC Amendment to WEEE: This Directive limits the amount of “heavy metals” permitted in the manufacture of electronic and electrical equipment. It is intended to reduce the level of heavy metals in recycling and landfills. As a practical matter it is now grouped with RoHS and is applied to virtually any and all plastic products manufactured or sold in the EU.
REACH: There will be volumes of books written about this regulation. In short, all chemicals that are manufactured or imported into the EU must be registered, then evaluated and their use restricted based on test findings. This legislation applies to; chemicals, blends of chemicals, concentrates, and Masterbatches. These items will all be noted as “preparations”. Finished products that do not intentionally allow release of a chemical are known as “articles” and articles do not require registration.
SVHC: This is a list of 16 chemicals that ECHA considers to be of high concern. Their presence in any preparation or article must be noted. Further they must be replaced wherever possible and their use restricted in a number of products.
LATIN AMERICA
OVERVIEW: Latin American Countries typically follow FDA Guidelines. Mercusor Countries (Argentina, Brazil, Paraguay and Uruguay) do have some separate guidelines as well. The regulations that refer to food contact packaging are: GMC Res. 25/99 and GMC REs. 46/06. These regulations are regarded to be used in addition to, and not in place of FDA regulations.
ASIA FOOD CONTACT
OVERVIEW: Asian Food Contact Regulations have not been well defined to date. Thailand and other countries have regulated levels of heavy metal
extractables of up to 100ppm, and other non-hazardous ingredients.
China’s Ministry of Health is releasing GB 9685. This will be a document that is essentially a “positives list” of additives etc. and is quite limited in scope. As of this writing it is not finalized yet and has not been translated. It is not clear yet if the document limits colorants. Presently, China still allows for an allowance of heavy metal content in food packaging.
It is expected that Asia in general will follow China’s lead once the document is finalized.
India currently has no specific quantitative limits, other than stating that food packaging should not impart anything hazardous into the food.
COMPOSTABILITY AND BIODEGRADABILITY U. S.
OVERVIEW
To be certified compostable a resin or finished product must meet ASTM 6400, OECD 208, EN 13432, ISO 16929, and 40 CFR Part 503.13. In the finished part the degradation is affected by the thickness of the part, so the thickest part must be submitted for testing. If colorants or additives are used, they can be present to a maximum of 1% in the finished product, and they only will require testing as to the heavy metal content and eco-toxicity in accordance with OECD 208. If they (colors and/or additives) exist in excess of 1% then the entire product must be submitted for compostability testing under ASTM 6400. OECD 207 Tests for earthworm toxicity are only necessary at this time if you intend to sell the product in Australia.
COMPOSTABLE PLASTIC DEFINITIONS
ASTM 6400: Outlines the requirements a plastic must meet to be labeled compostable, or biodegradable. It references test methods,
definitions, and other regulations related to composting and biodegrading of plastics.
OECD 208: Are the procedures that must be followed when testing the effect of compostable plastics on plant growth life.
EN 13432: Is the criteria for the how much of a package must degrade in a given period to consider it “recoverable”.
ISO 16929: This test determines the degree of disintegration of plastic materials under defined composting conditions.
40 CFR 503.13: Relates to the disposal of sewer sludge, in particular it references the limits of heavy metal content that is permitted
and thus limits the heavy metal content in a compostable plastic package to 50% of the sludge limit.
BIODEGRADABLE DEFINITIONS
OVERVIEW: To be considered biodegradable a plastic must meet the above criteria for compostable plastics, and additionally it must be able to
achieve degradation through the action of naturally occurring microorganisms such as bacteria, fungi, and algae.
COLORS AND ADDITIVES IN BIO-RESINS
In order for a color or additive to be used in a compostable or biodegradable resin and qualify the end product to be labeled as compostable
or biodegradable the following must be met.
- If the pigment or additive is below 1% (this does not include resin in the case of masterbatch or color concentrate) then it must meet both ASTM 6400 and OECD 208 criteria as it relates to heavy metal content.
- If the pigment or additive is above 1% then the finished product must undergo full compostability testing in accordance with ASTM 6400.
COMPOSTABLITY AND BIODEGRADABILITY CANADA
In principle, Canada follows the same requirements as defined by the US. However the metals concentrations that are permitted can be found in Table II of the Trade Memorandum T-4-93. In many cases, the metals limitations set by Canada as low as 50% of the level permitted under ASTM 6400.
COMPOSTABLITY AND BIODEGRADABILITY EUROPEAN UNION
The European Union follows the same guidelines as the US ASTM 6400 rules for determining compostability and biodegradability of plastic products. In Addition, the EU is very involved in the evaluation of full life-cycle analysis and package design. The Directive is: EU Directive 92/62/EC Packaging and Packaging Waste Directives. EU Full Life Cycle Product Law. Updated under the “Umbrella Standard” EN 13427:2004.