NATURE-THANX standard

The standard for natural, therapy-supporting care

NATURE THANX

A standard of the GfaW Society for Applied Business Ethics

Version 1.6/ 2024

All GfaW standards are not only open to any company that complies with the criteria, but are an explicit invitation to embark on the path to an economy that is sustainable and in harmony with the resources available.

1. preamble

This standard was created to enable consumers to recognize effective therapy-supportive care that is as close to nature as possible.

Consumers are increasingly demanding effective products to accompany therapy, but which have a minimally invasive effect on the environment. This standard is intended to create a regulation for this area of conflict.

The basis of the products must be of plant, animal, fungal or mineral origin. Contrary to natural cosmetics, nature-identical active ingredients that cannot currently be produced from plant, animal, fungal or mineral raw materials up to a defined quantity are not allowed. They are tolerated for the reason that they are indispensable for some therapy-supporting products. These special nature-identical active ingredients are described in the chapter “Permitted raw materials”.

As science is constantly discovering new active ingredients in nature, there is hope that petrochemical-based active ingredients or excipients can be replaced by natural ones.

The standard would like to be seen as groundbreaking in that it works with deadlines for substances that are currently still petrochemical-based and at the same time gives existing formulations, whose basis is of natural origin, the possibility of differentiation. Manufacturers are encouraged to strive for plant, fungal, mineral or – if the animal is not harmed – animal-based alternatives.

All GfaW standards are not only open to any company that complies with the criteria, but are an explicit invitation to embark on the path to an economy that is sustainable and in harmony with the resources available.

2. definition of terms

Foreign materials: Different material composition than the basic packaging – e.g. for sleeves or labels

kbA: controlled organic cultivation. Products and produce from organic farming in accordance with the EC Organic Regulation (Regulation (EC) No. 834/2007.

kbT: controlled organic animal husbandry. Products and products from organic animal husbandry in accordance with the EC Organic Regulation (Regulation (EC) No. 834/2007.

True to nature: corresponding to nature. In the understanding of the standard, this means that products made from either natural substances or/and modified natural substances or/and nature-identical substances according to the definition of this standard are collectively referred to as “true to nature”. The molecular structures of the substances can be found in nature, but the origin of individual ingredients may be of synthetic origin.

Nature-identical: A nature-identical substance occurs in nature in its molecular composition and form, but has been produced synthetically.

NATURE THANX: an abbreviated form of the standard name “Standard for natural therapy supportive care”

NIR: Near infrared. NIR (near infrared) refers to a spectrum in a range between 760 and 2,500 nm that is not visible to humans. In this wavelength range, typical material patterns based on molecular vibrations can be detected after excitation with light. This technology is used for sorting packaging.

Recyclability: Recyclability is the individual gradual suitability of packaging or a product to actually substitute material-identical virgin material in the post-consumer phase; “actually” here means that collection and recycling structures on an industrial scale are a prerequisite.

Recycled content: Proportion of recycled raw materials in relation to all raw materials.

Impurities: Substances that disrupt or prevent the recycling process according to the current state of the art.

Synthetic: This standard defines “synthetic” as anything that is the result of a chemical process that would not occur in nature and/or is of petrochemical origin.

Therapy supportive: supporting a form of therapy, a treatment or a medicinal product, but not acting as a medicinal product.

Composite packaging: Packaging that consists of different types of material that cannot be separated manually, none of which exceeds 95% by mass of the total packaging.

3 Impact and effects of the NCS standard

The aim of the standard is to replace petrochemical-based, genetically modified and environmentally harmful products with less environmentally harmful products. This requires consumers to recognize such products.

Another aim is to promote recyclable packaging in order to contribute to the circular economy.

In order to achieve these goals, NCS offers a means of differentiation at the point of sale with its catalog of criteria for ingredients and packaging as well as the NCS seal of approval for products.

Every product that is NCS certified contributes to realizing the transformation to a petrochemical-free and circular economy.

In detail, this means

The lowest possible environmental impact:

  • Strict criteria for petrochemicals
  • Only chemical processes permitted that also occur in metabolic processes in nature

As few products from genetic engineering processes as possible:

  • Strict criteria for ingredients involving genetic engineering

Promotion of organic farming:

  • Recommendation to use as many organically grown raw materials as possible
  • Obligation for organic quality for defined oils

The greatest possible proximity to nature:

  • If raw materials are obtained by means of chemical processes, these must correspond to the metabolic processes in plants/nature. They are listed in the standard.

Circular economy:

  • Criteria for the design of packaging in order of priority

Criteria for the permitted materials in accordance with the requirement to achieve the highest possible recyclability.

4 Scope of the NATURE THANX

The NATURE THANX standard regulates the requirements for certified natural therapy-supporting care products. Successful certification entitles the holder to use the term “NATURE THANX” or “NATURE THANX” and to use the NATURE THANX mark.

The NATURE THANX standard consists of criteria and annexes . The annex contains an open list of compliant INCIs (Annex 1) and a positive list of nature-identical substances (Annex 2). Annex 1 serves as a guide for product design. It is continuously updated with newly approved INCIs. The list of materials as a separate file supplements the criteria for packaging. Whether new raw materials, in particular from the field of nature-identical active ingredients, are included in the positive list is decided by the standard owner on the basis of the criteria with reference to a scientific committee. An application for the inclusion of a raw material in the positive list can be submitted to the standard owner for a fee.

5. general criteria

Only only raw materials and their manufacturing processes named in the NATURE THANX standard may be used in order to advertise the products with the NATURE THANX label and make reference to the NATURE THANX standard. The appendix contains a positive list of the natural raw materials and nature-identical inorganic pigments, minerals, preservatives and active ingredients approved to date. The required properties and qualities of the approved raw materials are described in the criteria.

Animal testing is not permitted in connection with the manufacture and sale of NATURE THANX-certified products.

The NATURE THANX Standard does not regulate any requirements with regard to the German Medicines Act, Cosmetics Ordinance, Food Supplements Ordinance, REACH or other laws or regulations. Manufacturers who use this standard for the labeling of their products comply with the applicable legal and regulatory requirements.

With regard to GMO freedom, the requirements of the EC Organic Regulation (Regulation (EC) No. 2018/848) apply to the end product and the raw materials used.[1] This requirement also applies to ingredients that would not fall under the Organic Regulation, such as substances from the non-food sector and non-organically certified material.

 

[1] The substances are not produced from, by or with the aid of genetically modified organisms. Proof is a GMO-free declaration from the manufacturer and, in case of doubt, a PCR analysis (the threshold value for an adventitious, technically unavoidable admixture is 0.9. Selected raw materials that cannot be produced without enzymes from genetically modified organisms according to the current state of the art and that are separately identified in Annex 1 are granted a tolerance period until the end of 2023. A query for the declaration of freedom is provided by the standard setter.

6. definition of the permitted raw material groups

The permitted ingredients for NATURE THANX products are divided into the following substance groups:

  • Natural substances: chemically unmodified raw materials of plant, inorganic-mineral or animal origin as well as their mixtures and reaction products with each other.
  • Near-natural raw materials: Raw materials obtained from a natural substance as defined above by chemical reactions described in the chapter “Near-natural raw materials”.
  • nature-identical inorganic pigments and minerals: substances whose chemical composition is identical to naturally occurring pigments and minerals.
  • Nature-identical preservatives: Substances whose chemical composition is identical to naturally occurring substances and are used as preservatives.
  • Nature-identical therapy-supporting active substances: Substances that fulfill the following properties:
  1. The therapy-supporting benefit has been proven
  2. The substance occurs in its chemical composition in nature
  3. The substance is obtained from nature. If extraction from nature is not ecologically and/or economically viable according to the current state of knowledge, technology and availability, it may be of synthetic origin.
  • Auxiliary and extraction agents
  • Aerosols: propellant gases
7. raw materials and their manufacturing processes

The following raw materials and processes may be used for production:

7. 1 Natural substances

Only physical processes using the extraction and auxiliary agents listed under point 2.5 may be used for the extraction of natural substances. In addition, enzymatic and microbiological processes are permitted, provided that only naturally occurring enzymes or microorganisms are used. Animal and vegetable raw materials must not be on the IUNC list of endangered species, unless they originate only from live animals from species-appropriate husbandry or from species-appropriate organic cultivation.

Critical substances in terms of sustainability, such as palm oil, should be avoided. If palm oil and palm kernel oil are unavoidable, they should at least come from RSPO cultivation. The standard setter recommends a supplier query of relevant points, also with regard to sustainability and the origin of the raw materials.

7.1.1 Natural plant substances

Natural plant-based materials are preferably sourced from certified organic raw materials.

The following plant-based raw materials come from certified organic sources:[1]

Sunflower oil, olive oil, soybean oil, coconut oil, jojoba oil.

Shea butter comes either from organic raw materials or from wild collection.

Chemically unmodified natural plant substances (essential oils, fatty oils, extracts, etc.) are not included in the positive list. Their use is permitted without restriction, provided that the relevant legal regulations, in particular health protection and other laws, are observed. It is therefore the responsibility of each manufacturer to use only safe raw materials.

Raw materials obtained by fermentation or biotechnological processes, as they occur exclusively in nature, are also not included in the positive list.

7.1.2 Animal natural products

Natural substances derived from living animals, such as milk or honey, may be used in NATURE THANX products. However, natural substances from dead vertebrates are not permitted. (e.g. collagen, fresh cells, etc.)

7.1.3 Natural mineral substances

Natural mineral substances are generally permitted as long as they have been obtained by physical methods. Mineral salts such as magnesium sulphate or sodium chloride may be used in NATURE THANX products. Exceptions to this are regulated under point 3 “Non-permitted substances”.

7.1.4 Fragrances

Fragrances that comply with ISO standard 9235 are approved for use in NATURE THANX-certified products. Biotechnologically derived fragrances can also be used.

Fragrances are not included in the positive list. The manufacturer’s confirmation of ISO 9235 conformity serves as proof.

[1] If the raw material is temporarily unavailable due to the geographical situation – emerging countries – crop failures or political conditions (trade boycott or similar), this unavailability is proven by documented demand from at least three different traders.

7.1.5 Water

Water is permitted. It is only classified as a natural substance if it comes directly from plant sources. In this case, it can be labeled as such if the organic quality of the source material is proven.

7. 2 Near-natural raw materials

Natural raw materials may be obtained from natural substances according to the above definition by the following chemical reactions: Hydrolysis (including saponification), neutralization, condensation with elimination of water, esterification, transesterification, hydrogenation, hydrogenolysis, dehydrogenation, glycosylation, phosphorylation, sulphation, acylation, amidation, dimerization, oxidation (with oxygen, ozone or peroxides) and pyrolysis.

The use of organohalogen compounds for the extraction of near-natural raw materials is not permitted.

The approved INCIs of near-natural raw materials are listed in the positive list. Proof of conformity of a raw material and its INCIs must be submitted for testing.

7. 3 Nature-identical raw materials

Inorganic pigments and minerals

In NATURE THANX-certified products, the nature-identical pigments, minerals and active ingredients listed in the positive list can also be used.

Nature-identical preservatives

For the purpose of product safety, the following nature-identical preservatives may be used if necessary:

– Benzoic acid, and its salts and ethyl ester

– Salicylic acid and its salts

– Sorbic acid and its salts

– Benzyl alcohol

– Formic acid and its sodium salt

– Dehydroacetic acid and its salts*

– Propionic acid and its salts*

When using these preservatives, the addition: “preserved with … [Name des Konservierungsstoffes]” is required on the outer packaging in the field of vision of the INCI list.

* As far as authorized by Directive 76/768/EEC, except ethanolamine salts

Nature-identical therapy-supporting active ingredients

The authorization of nature-identical therapy-supporting active substances must be justified. The justification shall be proof that the substance has a therapeutic efficacy and that the efficacy of the current active substance cannot currently be achieved with natural substances or that no alternative has yet been found that is of plant or animal origin and can be obtained using the manufacturing processes referred to in paragraph 2.2.

In order to promote research and development in the interests of sustainability, the standard setter queries the justification for the active ingredient every 3 years. Every user of the NATURE THANX standard endeavors to find plant- or animal-based alternatives.

Currently, the following quantities of nature-identical therapy-supporting active substances are tolerated:

Active ingredient

Max. Content in the product

Allantoin

1%

Urea

25%

Panthenol

5%

Biotin

1%

 

7. 4 Auxiliary and extraction agents

The following are permitted as extraction agents for natural substances: Water, vegetable alcohol, carbonic acid, vegetable fats and oils, glycerine of vegetable origin. Furthermore, enzymatic and microbiological processes that also occur in nature may be used. Extraction agents that do not conform to the NATURE THANX standard are only permitted if an alternative extract is not available and the extraction agent has subsequently been removed down to a technically unavoidable residue.

Pre-preservation and technical additives must comply with the NATURE THANX standard if they remain in the end product (see point “Nature-identical preservatives”). The only exceptions are additives that are used and removed as far as possible using state-of-the-art technology (e.g. solvents).

All raw materials and additives contained in the product, in particular pre-preservatives and solvents, must be reported with INCI names.

7. 5 Aerosols

The propellant gases are components of the cosmetic product. The following propellant gases are permitted in NATURE THANX-certified products: CO2, nitrogen, compressed air

8. non-permitted substances

Substances from the following substance groups may not be used in NATURE THANX-certified products:

  • EDTA complexing agents, glutaraldehyde, formaldehyde or formaldehyde releasers
  • Organohalogen compounds
  • Synthetic fats, oils, waxes or silicones
  • Aromatic amines, ethanolamines and derivatives
  • synthetic fragrances
  • Ethoxylated auxiliary and raw materials
  • Musk compounds
  • Phthalates
  • PEG and PEG derivatives
  • Solid, insoluble polymers, especially if they are smaller than 5 mm.
9. radioactive irradiation and nanomaterials

The treatment of plant and animal raw materials and the end products with ionizing radiation is not permitted.

Ingredients that must be labeled as “nanomaterials” according to the Cosmetics Regulation are not permitted in NCS-certified products.

10. packaging

Valid for all from 01.01.2024 to be purchased packaging.[1]

Natural products in environmentally harmful packaging do not go together. Especially not if the packaging gives a green impression, even though it interferes with the recycling process or is even non-recyclable. The standard sets its criteria against such greenwashing packaging:

These packaging criteria apply to products that are marketed under the company’s own brand or produced in-house for end consumers. Packaging for B2B transport or sales is not covered here.

In principle, care should be taken when using packaging materials and packaging materials to ensure that the packaging task can be fulfilled with the lowest possible overall impact (economic, social, ecological).

The impact must always be determined across the entire value chain (raw material production, processing, logistics, use, end of life, reprocessing and new raw material use).

Packaging is used in the following order of priority:

  1. Priority Avoid: As little as possible. The key question is: Is the packaging indispensable?
  2. Priority Reduce: The packaging that is required should use as little material as possible. The key question is: Can the packaging material be reduced, e.g. through refill options?
  3. Reuse priority: Prefer reusable to disposable packaging. This means that before designing single-use packaging made from recyclate, it must be clarified whether a reusable system, regardless of its form, would be possible. The key question is: Is there a reusable system for the planned packaging?
  4. Recyclability priority: Recyclability of packaging and packaging materials, which is required by the EU and in Germany. This is not about the theoretical recyclability of materials, but about the recyclability of a complete packaging material (including closure and labels) in the existing recyclable material streams. The key question is: Is the packaging actually recyclable at present? Can the consumer simply assign it to the appropriate recycling streams? [2]
  5. Priority emptiability: Residual emptiability of the packaging. In order not to disrupt the sorting and recycling process, the packaging must be easy to empty. The key question is: can the packaging be completely emptied?

The materials listed in the appendix, which are marked green, may be used.

All materials marked in orange and red are contaminants for the recycling process.

The materials marked in orange are tolerated, but are currently not recommended by the standard setter.

The materials marked in red must not be used.

As the technical possibilities of the recycling industry are subject to immense change, the list of materials is reviewed by the standard setter every two years to ensure that it is up to date and adapted if necessary.

In addition, the following minimum requirements apply to the materials:

Paper packaging:
Fully recycled paper materials are preferable to virgin paper.

The recycled content of paper packaging is at least 50%.

Raw paper materials come from either FSC or PEFC sources.

The paper must not be bleached with chlorine or chlorine derivatives. Only TCF is permitted.

In particular, wet strength agents, grease sealants and PFC-based finishes are not permitted. Coatings and laminations should generally not be used on paper materials.

Wood-based packaging:

The wood comes from FSC or PEFC sources. The packaging must be designed in such a way that different materials can be separated.

Plastic packaging:

No multilayer structures, except PE/PP-EVOH.

Requirements for the proportion of recyclate in plastic packaging in relation to the product type:

Material / product type

Food

Cosmetics

Natural products

PET

90%

90%

90%

PP

-*

50%**,***

90%**,***

PE

-*

50%**,***

90%**,***

*The possibility of using PE and/or PP with recycled content for foodstuffs will be adapted to market conditions by the standard setter. Currently (as of the end of 2023), no food conformity can be achieved with rPE and rPP.

** Unless an in-house recycling plant has been set up and the return rate is not 90% and the material to be purchased is contaminated with synthetic fragrances or genotoxic substances.

***Does not apply to parts of the packaging that come into contact with the product if food conformity is required.

No different plastics on the front and back. Recyclable printing inks (minimum standard[1]EuPIA-compliant printing inks). When using labels or sleeves made of foreign material, they are smaller than 50% of the packaging surface (see minimum standard for impurities NIR).

No PETG sleeves or components for PET bottles.

No cellulose-based labels permanently attached to polyolefin packaging except for overlaminating standard labels or to save repackaging.

No silicone components.

Adhesives:

Only REACH-compliant adhesives may be used.

 

[1]https://www.verpackungsregister.org/fileadmin/files/Mindeststandard/Mindeststandard_VerpackG_2021.pdf

[1] Explanation of the criteria and recommendations for action

Section 21 of the Packaging Act* provides for the implementation of financial incentives for the use of recyclable packaging. No recyclability will result in a payment by the distributor, but the use of at least 90% recyclable packaging will result in a refund.

The standard setter therefore recommends not only adhering to the minimum requirements in this standard, but also following the recommendations, both from a financial and environmental perspective.

Fiber materials in particular are often assumed to be recyclable as a matter of course. However, this can be undermined by the wrong or too thick coating, by hot melts in folding boxes or by coatings and finishes. The PTS-RH 021 97 standard provides information on the recyclability of fibrous materials. The origin of fibrous materials should also be checked, as around half of cellulose comes from Latin America and from eucalyptus monocultures. To avoid supporting this trend, it is important not only to see the certificate number of the producing company in the FSC supply chain traceability, but also to list the numbers of the raw materials used.

The recyclability of composite material, plastic, glass and metal packaging is confirmed by companies such as HTP-cylcos, Interseroh and Clover. The EU is working on establishing a circular economy, so it makes sense to use as much recyclate, used material or cullet as possible in packaging. The use of recyclate, for example in the fiber sector, also ensures that the raw materials come from domestic collections rather than sources from other continents.

*Section 21 Ecological structure of the participation fees

(1) Schemes are obliged to create incentives within the framework of the assessment of participation fees in order to

the production of packaging subject to system participation

  1. to promote the use of materials and combinations of materials that take into account the

practice of sorting and recovery can be recycled to the highest possible percentage, and

  1. promote the use of recyclates and renewable raw materials. …” (Packaging Act of 05.07.2017)

[2] This means that the packaging/packaging materials should be marked in such a way that the consumer can assign them to the correct material stream. It must also be possible to automatically identify and sort packaging materials (NIR technology for sorting recyclable materials). In addition, it must be possible to process them in the existing material streams and convert them back into raw materials/packaging materials at an economical rate.

11. good professional practice

The company that manufactures and/or markets NCS-certified products has set up a quality management system (QM system) for traceability and quality controls in accordance with HACCP and cosmetics GMP (ISO 22716). The QM system must be expanded to include environmental protection and sustainability measures in the course of continuous improvement. Orientation towards the Certified Sustainable Economics (CSE) standard is helpful here.

Packaging of NATURE THANX-certified products is recyclable (e.g. glass, aluminum, paper/cardboard, PET, PP, and others). Unnecessary outer packaging that is purely for marketing purposes should be avoided. The design of the packaging enables complete emptying.

12. conditions for the award

NATURE THANX-certified products may be advertised as “certified natural therapy-supporting care” or as “NATURE THANX” and bear the NATURE THANX symbol.

A NATURE THANX-certified product may be labeled as vegan and bear the NATURE THANX vegan symbol if no ingredient is derived from or by animal substances.

The ingredients are listed on the packaging using the INCI list and everyday language.

In the case of the presence of ingredients with organic quality in the certified products of the “natural cosmetics” level, the following conditions must be complied with:

  • Claims relating to the organic quality of the ingredients used are only permitted if they are labeled in such a way that they can be clearly and precisely assigned in the mandatory index of ingredients. The statement “organic quality” refers to the organic source material in accordance with the standard. For example, the reference to organic quality with “*” can be used as a precise indication. The regulation applies both to the wording “organic” and to all synonymously used expressions such as “eco”, “organic” or “controlled organic cultivation”. The language chosen for the claim is irrelevant.
  • The proportion of organic ingredients must be stated as a percentage of the proportion of all ingredients in the end product. The percentages are given in whole numbers, fractions are rounded up. A permissible indication of the percentage share is, for example:

“70% organic ingredients in the product, 100% of which are organic”

The following should be noted when calculating the percentages: Undiluted ingredients in organic quality are recorded in their full proportion by weight, e.g. plant parts, pressed oils, pressed juices, microorganisms in their solutions and essential oils.

  • Ingredients in organic quality are recorded in their full weight proportion, e.g. plant parts, pressed oils, pressed juices and essential oils.
  • Plant extracts in organic quality can be recorded in their full weight proportion if the extraction agent is no longer contained in the end product (e.g.CO2 extraction) or the remaining extraction agent is of organic quality.

The following formula is used:

  • X= P/(P+E) x 100

X = organic content in the extract; P = mass of plant material used; E = mass of extraction agent used

The weight of concentrates is not determined before concentration. The water that is added back to the concentrate is also not taken into account.

13. supplier exchange

Replacement of the raw material supplier is possible without notification of change if the raw material in question is not subject to any quality requirements, e.g. natural materials.

If the raw material is subject to quality requirements, conformity with the NATURE THANX standard must be demonstrated during testing.

The standard setter also recommends a supplier inquiry with regard to sustainability and human rights. The standard setter will provide templates for this on request.

14. inspection and certification procedures

The certification and inspection bodies approved by the GfaW standards work in accordance with ISO 17065 and have many years of experience in certifying natural products. GfaW concludes contracts with the certification bodies for the performance of certifications in accordance with the GfaW standards. These contracts regulate the inspection and certification procedure, the qualifications of the assessors and auditors, the frequency and intensity of the assessment, sampling protocols for the assessment, sources for the evidence to be assessed, minimum content of assessment reports and deadlines for the submission of completed reports following the assessments. GfaW is responsible for monitoring compliance with the contractual agreements.

Certification process

There is a two-stage process for certifying the products:

  1. Stage: Testing of the products including proof of quality requirements in accordance with the standard
  2. Stage: Implementation of initial audit GMP basic requirements, packaging and labels
  3. Stage: Annual monitoring audits

The certificate issued entitles the holder to use the respective mark, which is awarded by the GfaW Gesellschaft für angewandte Wirtschaftsethik.

Further monitoring of conformity takes place through on-site audits depending on the risk classification.

Deviations and sanctions

If a product does not comply with the standard in stages 1 and 2, it does not receive a certificate. Stage 3 does not take place until all ingredients are compliant. The applicant then has time to change their recipe or replace the non-compliant raw materials.

If deviations from the standard are identified at level 3, reactions and sanctions are imposed, including withdrawal of the certificate and prohibition of use of the label.

Application procedure

To register the products, the company receives a registration file from the certification body or access to digital registration software. Companies registering products for the first time enter company data that is relevant for certification.

Listing of components for product registration

Among other things, a list of all ingredients contained in the product with the INCI contained is required in the product declaration. This is not(!) only the INCI declaration of the product. All the raw materials contained (if mixtures such as pre-preserved plant extracts are used, extraction agents and pre-preservation must also be listed).

The type and materials of the packaging must also be specified.

The certification body shall be informed immediately and without being asked of any changes relating to conformity with the GfaW standards.

Exchange with the certification body

For quality assurance of the GfaW standards, the certification body prepares a report on non-conformities once a year. This report is subject to confidentiality and serves the GfaW as a basis for topics in working group meetings, determining the need for consultation and evaluating the impact framework.