1. Introduction

Welcome to AllergyCertifieds criteria document. Our main focus is to prevent skin allergies also known as Type IV allergies and make it easier for those who already have an allergy to find skin-friendly products.

We check products carefully to make sure they don’t contain any ingredients in concentrations that might cause skin allergy. But we don’t just stop at allergies. We also look out for other side-effects, such as known carcinogenic and endocrine effects.

By conducting a comprehensive third-party assessment on each product, we provide assurance that certified products have undergone thorough risk assessment and fulfil our stringent criteria.

Our certification criteria are designed to provide a straightforward way for brands to ensure and showcase the safety of their products concerning skin allergies. While the criteria cover a wide range of product categories, each with some unique requirements, they share a common foundation aimed at promoting skin-friendly products.

The following sections outline the general criteria that form the core of our certification, along with a detailed look at the specific criteria for each product category. This thorough framework is designed to reduce allergy risks and help you towards achieving the AllergyCertified certification

2. General Criteria

To have your products certified with us, you must be aware that there are ingredients we never allow. These include known allergens such as all types of perfumes, whether natural or synthetic, as well as certain preservatives like Methylisothiazolinone and resin/colophony. The reason is that these chemicals can cause allergy in even very low concentrations.

General Requirements

To become certified, your products need to undergo a risk assessment. For this comprehensive knowledge of all ingredients is necessary, including additives and impurities present in raw materials.

The following information is required: INCI names¹, CAS numbers², the specific concentration of each ingredient, safety data sheets (MSDS/SDS) for raw materials, technical data sheets (TDS)/ raw material dossier, and a 100% composition breakdown for raw materials (additives).

This information is crucial for our work, and we cannot fulfil a risk assessment and certify a product without this information, nor can we certify products based on a list of what’s not in the product.  

Reason for documentation

MSDS/SDS provides comprehensive information about the chemicals properties and hazard classifications such as H317 sensitization (allergy). Full composition breakdown can sometimes be found in the SDS/MSDS but it’s not a legal demand, only classified chemicals must be in the MSDS/SDS so this type of document will often not contain important information about impurities and additives in the raw material.

TDS/COA is useful for identifying impurities in the product. Some substances may contain impurities with unwanted health effects like allergens or endocrine disruptors. Additionally, pigments can contain heavy metals including nickel.

100% composition breakdown is vital because raw materials may contain additives like preservatives or stabilizers not listed in the product formulation or in MSDS or TDS. By getting this documentation we can see all the chemicals used in the raw materials or if the materials contain additives like preservatives or stabilizers not listed in the product formulation. If your supplier doesn’t have a document with 100 % composition breakdown, they can fill our “declaration of raw materials. “This document can be found in our customers database Redmine under Criteria// information.

Laboratory Testing

If you use chemicals known to contain impurities that can be allergenic, we will demand a laboratory test from an external laboratory.

Classified chemicals

Ingredients classified with these H-phrases are generally not allowed unless the chemical is used in a specific product where it poses no risk issue, or if The Scientific Committee on Consumer Safety/SCCS³,

Cosmetic Ingredients Review/CIR⁴ or our advisory board⁵ finds that it won’t cause allergic reactions.

Sensitization and skin effects

H310 Fatal in contact with skin
H311 Toxic in contact with skin
H312 Harmful in contact with skin
H314 Causes severe skin burns and eye damage.
H315 Causes skin irritation (depends on product type and concentration: leave on, rinse off)
H317 May cause an allergic skin reaction.

Cancer

H350 May cause cancer.
H351 Suspected of causing cancer.

Reproduction

H360 May damage fertility or the unborn child
H361 Suspected of damaging fertility or the unborn child.

AllergyCertified products are not allowed to contain

Perfume

Whether synthetic or natural perfumes, essential oils, or aromas, these are not allowed.

Preservatives not allowed:

Formaldehyde and Formaldehyde Donors

Benzylhemiformal
2-bromo-2-nitropropane-1,3-diol
5-bromo-5-nitro-1,3-dioxane
Diazolidinyl urea
DMDM hydantoin
Imidazolidinyl urea
Methenamine
Paraformaldehyd
Sodium hydroxymethylglycinate
Quaternium-15

Preservatives

Methylisothiazolinone (MI)
Methylchloroisothiazolinone (MCI)
Kathon MI/MCI

Acrylates

Specific acrylates like Methacrylate’s are not allowed. If acrylate appears as an impurity in another ingredient, we can allow it only if there is a safe NOAEL value⁶⁶ and the impurity is below the NOAEL value.

Example on some extracts which are not allowed

• Brassica Alba sprout extract
• Barosma betulina leaf extract
• Cystoseira tamariscifolia extract
• Emiliania huxleyi extract
• Helichrysum angustifolium flower extract
• Lavandula angustifolia flower extract
• Raphanus sativus (radish) root extract
• Rosa damascena flower extract
• Salvia officinalis leaf extract
• Thymus vulgaris extracts
• Spilanthes acmella flower/leaf/stem extract (H317)
• Porphyridium cruentum extract (insufficient data)
• Rosemary

These are only examples of some chemicals we can or cannot allow – why is there not a full list

While positive and negative lists would greatly simplify our work, it’s unfortunately not always feasible to use them when dealing with allergies. Skin allergies are concentration-dependent, meaning certain substances can be allowed only in specific concentrations. Additionally, there can be variations in exposure, such as the type of product a substance is used in. As an example, if a substance is an eye irritant, it can be safe to use in a high concentration in a foot cream, but in eye creams the concentration must be low to prevent eye irritation. When multiple substances with potential skin or eye irritation properties are used, even lower concentrations are allowed.

Substances with the same INCI names can have varying properties based on their purity. Thus, documentation proving the absence of potential allergenic impurities is required, and the type of product they can be allowed in may vary accordingly.

Furthermore, substances safe for use in ex. conditioners or a bodylotion may pose risks if ingested (due to food allergies or toxicity), making them unsuitable for lip products. For example, purified Petrolatum is effective in eczema creams but can be toxic if ingested. Therefore, we only allow refined Petrolatum in products where ingestion risk is minimal, excluding lip products. Similarly, unrefined almond oil can be safe in body oils but may cause food allergies in lipsticks

Interactions between substances should also be considered. For instance, high concentrations of alcohol are necessary in products like hand sanitizers, but they can be irritating and drying to the skin. Thus, we require the addition of glycerin to counteract this effect.

In order to make sure that the ingredient you want to used can be allowed, you must add the raw material to our client database with MSDS, TDS/CoA and 100 % composition breakdown for assessment.

Ingredients of food origin in certified products:

Skin allergies and food allergies are distinct, typically unrelated types of allergies. This means that if someone is allergic to nuts, they usually won’t react to a cream containing nuts when applied to the skin. However, there have been instances where certain food substances applied to the skin, such as Wheat Protein, can trigger food allergies. Studies show that it depends on the protein’s size. Therefore, we only allow substances like Avena Sativa Kernel Extract if their size is above 3500Da, as smaller sizes may induce such reactions.

Examples of oils which can be used in AllergyCertified Product (for some AC require documentation for their purity)

• Aloe Barbadensis (depends on Antraquinone)
• Butyrospermum Parkii Butter
• Brassica Campestris Oleifera
• Borago Officinalis Seed Oil
• Brassica Oleracea Italia
• Brassica Napus Seed Oil
• Coconut oil refined
• Cucumis Sativus Fruit
• Elaesis Guineensis Oil/Elaesis Guineensis kernel Oil
• Heliathus annuss seed oil (refined)
• Hydrogenated Canola Oil
• Jojoba oil Olus Oil
• Olea Europaea Oil
• Prunus Amydalus Dulcis Oil (REFINED)
• Prunus Armeniaca Kernel Oil
• Persea Gratissima Ricinus Communis Oil
• Shea butter
• Simmondsia Chinensis Seed Oil

If you wish to use an oil not listed here, you can provide us with the INCI and CAS numbers for further investigation. Skin allergy is concentration-dependent, so precise concentration details of impurities are required for risk assessment.

Non-Disclosure Agreement

Given our daily handling of confidential information, we can offer a signed non-disclosure agreement (NDA). If you require an NDA with us, please inform the certification agent who will be working with your products. Given that we work with over 150 international companies, managing numerous NDAs tailored to each partner’s requirements becomes unfeasible. Therefore, to ensure efficiency and consistency across our partnerships, we exclusively utilize our standard NDA.

3. Cosmetic Products

Manufacturers applying for the AllergyCertified certification are expected to comply with relevant legislation. For products sold in Europe, this includes the EU Regulation on cosmetic products EC No. 1223/2009, EU REACH Regulation (EC No. 1907/2006), and the Commission Regulation on claims used concerning cosmetic products (EU No. 655/2013). 

For products sold outside the EU, it is expected that national laws regarding cosmetic products are followed as a minimum. 

Safety Assessment

The EU’s cosmetics regulation ensures that cosmetic products in the European market are safe for consumers. A requirement is a safety assessment of the cosmetic product to ensure compliance with current rules. 

AllergyCertifieds criteria extend beyond the Cosmetics Regulation, thus being more stringent than the legislative requirements and safety assessments. AllergyCertified evaluations are based on risk assessment, not just hazard. Therefore, products deemed safe by a safety assessment might not achieve certification. 

Raw Materials

AllergyCertified must have complete information about the raw materials used in your cosmetic product. This includes the raw material name, Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and a 100% composition breakdown (if the raw material supplier does not have a document where composition is evident, they must fill out the “Declaration of Raw Materials” document. This document can be found in Redmine under Criteria /Information. 

Each raw material must be registered separately and will receive an issue number upon registration. After registration, we require the actual recipe of the product. You must fill out our recipe template with INCI, CAS number, concentration, raw material name of the substance and the issue number (the number assigned when you registered the raw material). You can find both a written manual and also a short film about this in Redmine under criteria/information. 

Laboratory testing

We demand laboratory tests for certain contaminants such as Perfumes, nickel, cobalt and formaldehyde. 

Getting Started 

AllergyCertified operates in Redmine, a secure database. To certify a product, your company must be registered and have a user account in our database.  

After registering and setting up a password, you can start uploading formulations and raw materials. All documents, including MSDS, TDS, and 100% composition breakdown, must be provided when creating a raw material. 

If data is incomplete, wait until you have all information before creating the raw materials, as we require full documentation. 

Assessment Process

After evaluating raw materials, they’ll be marked as approved, approved but pay attention to… (certain considerations apply), or rejected. The system sends notification emails when the assessment is complete or if data is missing, and you can reply to us directly in Redmine by writing in the field called notes.  

User-friendly manuals are provided to help you navigate the system and can be found in Redmine under Criteria//information  

People to contact

https://www.allergycertified.com/founders/

For contract and cost inquiries, please reach out to Lene Still at lene@allergycertified.com  or phone +45 5363 3760

If you need assistance with requirement and risk assessment or have questions about our criteria or chemicals contact Ewa Daniel at ewa@allergycertified.com or phone +45 2721 3760

1. INCI: International Nomenclature of Cosmetic Ingredients. It is a standardized system used in the cosmetics industry to name ingredients (chemicals) that are used in cosmetic products. INCI names are designed to provide a consistent and internationally recognized way of identifying cosmetic ingredients, helping consumers and regulators understand the contents of these products.
   As an example, the INCI name for water is Aqua. ↩︎
2. CAS: Chemical Abstracts Service. CAS are unique identifiers used to represent specific chemical compounds. Each CAS number is a unique numerical code assigned to a particular substance, and it helps ensure that chemicals are accurately identified and distinguished from one another. For example, water with the INCI name Aqua is represented by the CAS number 7732-18-5 ↩︎
3. SCCS is a scientific committee for Health and Consumer Protection under the European Commission. SCCS provides Opinions on health and safety risks (chemical, biological, and other risks) of non-food consumer products (e.g. cosmetic products and their ingredients, toys, textiles, personal care and household products). ↩︎
4. CIR is an expert committee that assess chemicals used in cosmetic products. CIR relies heavily on INCI when identifying the ingredients to be assessed. ↩︎
5. You can read about our advisoryboard on our website: https://www.allergycertified.com/advisory-board/ ↩︎
6. No Observed Adverse Effect Level.” Is used in toxicology and risk assessment to describe the highest dose or exposure level of a substance at which no adverse effects or significant adverse effects are observed in a specific study or experiment. ↩︎