Background

In the design of its materials Sulapac pays great attention to all phases of the material life cycle. Sulapac’s co-founders have their academic background in biomedical*) materials, which means that safety is in the DNA of all Sulapac’s materials. Naturally, when we say a material is safe, we mean it is safe for its intended use. 

Promotion of circular economy is one of Sulapac’s key priorities. By designing materials, the raw materials of which are inherently safe for people and the environment, we can promote cycles which are safe on the molecular level. Our ambitious objective has been to develop ‘bio-benign’ materials that would reduce the negative impacts on natural systems when leaked, while also being recyclable and competitive in terms of functionality and costs. Our leading design principle is to mimic the nature. 

*) Biomedical materials are materials which are biocompatible meaning they can be placed in human body on medical purposes 

Key feature

Sulapac materials are safe for people and the planet. The main raw materials utilized are biodegradable biopolymers and natural fillers, such as sustainably sourced wood originating from industrial side streams.  All raw materials are sustainably sourced and food contact compliant. Furthermore, we only use raw materials which do not cause long-term adverse effects in the environment. No release of harmful chemicals or permanent microplastics takes place during the use and end of life of Sulapac materials. 

Sulapac materials are manufactured in accordance with (EC) No 2023/2006 Good Manufacturing Practice for materials and articles intended to come into contact with food. 

Criteria and validation¹⁾

Sulapac Flow 1.7 & 1.8, Solid 2.0, Luxe Flex, Universal and Premium materials have been evaluated and validated against the following legislations and criteria. Compliance with the applicable regulations is the basis for a material to make it to Sulapac portfolio, and we have set ourselves additional criteria to further ensure safety of our materials for both people and the planet: 

Food contact compliance

EU 

The European food contact legislations (EU) No 10/2011, (EC) No 1935/2004 and (EC) 2023/2006. Customers to please note: the converter or packer has to check the suitability of the article for their own application. 

US FDA (not applicable to Sulapac Luxe Flex)

All individual substances are covered by either: 

• a regulation listed in Title 21 Code of Federal Regulations 

• meeting the criteria for GRAS status (including but not limited to a GRAS regulation or GRAS notice) 

• or an effective Food Contact Substance Notification (FCN). 

The aforementioned Sulapac materials are produced from substances which comply with the specifications and limitations in all applicable authorizations. Compositionally, Sulapac materials comply with the requirements of the United States of America U.S. Food and Drug Administration Code of Federal Regulations.  

Absence of heavy metals

EU Directive 94/62/EC on packaging and packaging waste, Article 11, limits heavy metals to cumulative content of Pb, Cd, Hg and Cr(VI) not exceeding 100 ppm.  This same limitation is a requirement in the US CONEG-regulation / Toxics in Packaging Clearinghouse. Sulapac materials comply with this limitation.  

Chemical compliance – EU REACH

Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH compliant means that all relevant substances are: 

• excluded from the regulation, and/or 

• exempted from registration, and/or 

• manufactured/imported under a valid pre-registration until May 31, 2018 and/or 

• have been registered. 

Sulapac materials are not intentionally formulated to contain the substances listed as Substances of Very High Concern (SVHC), or any other CMR 1/2, PBT or vPvB substance in concentrations >0.1% (w/w) 

Chemical compliance – CLP

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. Based upon our knowledge of the manufacturing process of Sulapac materials and information provided by raw material suppliers, the following chemicals are not expected to be present in Sulapac materials  

• Skin sensitizer above 10 ppm or 10 ppb (migrating in simulant) 

• Carcinogenic, Mutagenic, or Reproductive Toxins above 1ppm or 10 ppb (migrating in simulant) 

Safe formulas²⁾ 

Hazardous chemicals listed in California Proposition 65 are generally speaking not intentionally used in Sulapac materials. However Sulapac materials are produced using natural raw materials, and some of these are listed in California Proposition 65, such as wood dust. There is also a possibility that trace amounts of listed chemicals may occur naturally or form as a by-product of processing of organic materials.  

The Sulapac materials mentioned above are not intentionally formulated to contain any of the following substances 

• Animal derived substances 

• Bisphenol A and its derivatives 

• Halogenated Polymers (PVC and PVdC) 

• Persistent Organic Pollutants (POPs) as per (EU) No 2019/1021 

• PFAS 

• Phthalates 

• Polycyclic aromatic hydrocarbons (PAHs) 

Non-GMO

Given the definitions in regulation (EC) No 1829/2003 on genetically modified food and feed, only non-GMO raw materials have been used in the production of these Sulapac materials.  

Please note that this statement does not apply to materials with recycled content, as verification of feedstock origin on collected recyclables is not possible.  

Ecotoxicity tests

These Sulapac materials have passed EN13432/ ASTM D6400 ecotoxicity tests performed by a third-party laboratory. This involves testing that the biodegradation products are not ecotoxic by making an examination to see if the germination and biomass production of plants are not adversely affected by the influence of composted sample.  

Additionally, Sulapac Flow material has successfully been analyzed in the Daphnia magna plankton toxicity test (according to OPPTS 850.1010 & OECD 202) performed by a third-party laboratory: test series showed that the degradation products of Sulapac Flow are non-toxic, and therefore, do not have any harmful effect on the plankton in the marine ecosystem. 

No microplastics accumulation

Sulapac materials are biodegradable in the sense that they do not leave behind permanent microplastics. As all other biopolymers, such as collagen and native cellulose, Sulapac disintegrates first into tiny particles. However, in contrast to conventional plastics, after disintegration Sulapac materials biodegrade on molecular level into CO2, water and biomass in open environments within a similar time frame as naturally occurring biological materials such as wood and tree leaves.  (For details see Key feature No permanent microplastic). 

Organic recycling 

These Sulapac materials are industrially compostable. For details, see Key Feature “Industrially compostable”.  

1) Nothing herein is to be construed as a warranty, express or implied. It is the responsibility of the user to determine the applicability of such information or the suitability of any products for their own particular purpose. 

2) Sulapac materials are technical products, therefore we cannot rule out the possibility of minimal contamination due to other influences. It should be noted that we do not measure the content of such contamination as a part of our end control procedure.