Workbook for preparing a technical dossier for cosmetic ingredients

A cosmetic ingredient dossier organises the data and other information about your ingredient so you can prepare your offer to buyers in the cosmetic ingredient sector. It contains data sheets and other technical information that you need to promote your ingredient in Europe and meet European market requirements. This workbook contains information on what to include in a dossier and how to prepare it, including the technical data sheet (TDS) or specification, the safety data sheet (SDS), certificates of analysis (CoA) and a product data sheet (PDS) or sell sheet. The workbook also includes key references regarding information about social responsibility and how to meet buyers’ expectations.

1. Why do you need to have a dossier?

The cosmetic ingredient dossier, electronic or in print, is the central reference of information about your ingredient, both from your own knowledge as well as from secondary sources. In the eyes of a buyer, you are the expert on what you are offering. The dossier becomes the source of information from which you become that expert. The dossier has to respond to the needs of the cosmetics industry and what they are looking for in their cosmetic ingredients.

All cosmetic ingredients have to meet the standard legal and market requirements of safety and efficacy, as well industry expectations in relation to price, volume and reliability of supply.

In addition to these requirements, cosmetic brands are also looking for the following set of desirable characteristics:

Natural

The industry is constantly looking for more natural ingredients, also commonly referred to as ingredients of natural origin.

Innovative

The cosmetics industry is always looking for innovative ingredients that meet the requirements imposed on all other cosmetic ingredients.

Origin

The cosmetics industry is looking for ingredients with an interesting or different origin. This includes not just the geographic origin, but also traditions of use, local benefits and production methods, among other things.

Social responsibility

Social responsibility is one of the main concerns of the cosmetics industry, after safety and efficacy. Consumers expect high standards of social responsibility regarding care for people and the planet. It is not only a business-to-business activity: social responsibility starts with traceability in the supply chain, but extends to ensuring that at least the minimum norms of social responsibility are respected throughout the supply chain. This may or may not involve certification, depending on the expectations of a particular customer.

The cosmetic ingredient dossier is the source of all the data and information needed to prepare the technical documents and promotional materials that relate to the above requirements and expectations of industry.

Elements of a cosmetic ingredient dossier

You can structure the document by dividing it in chapters on safety, efficacy, CSR and other legal and market requirements, using the information and data described in Table 1 below. The content of each chapter should enable you to provide information and data on the topics of each chapter as follows:

Table 1: Elements of a cosmetic ingredient dossier

For this guide we are going to focus on the technical documentation and aspects of corporate social responsibility.

The importance of technical documentation

The cosmetics industry is a branch of the chemical industry. European cosmetic industry legislation is based on a risk management approach. This means there must be a good understanding of the maximum levels of chemical components that can be used safely in cosmetics, including a proper margin of safety. The ingredients dossier contains the raw data and information to make decisions on safe use of the ingredient in a cosmetic product.

For example, essential oils are powerful chemicals and generally must not be used directly on the skin. The industry and its regulators investigate the maximum safe concentrations in cosmetic ingredients and their individual components and ensure adherence to these maximum levels, either through legislation or industry codes of practice.

The dossier for an essential oil contains the data relevant to the determination of maximum safe concentrations in actual use. The dossier must include a description of the full chemical composition of your ingredient, including any impurities. Understanding the chemical composition of a cosmetic ingredient is a fundamental principal of the industry. Without a clear understanding of its full chemical composition, it is not possible to make a conclusive statement on the safety of that ingredient. If the full composition is not known, two main risks remain:

• that certain dangerous components may have not been tested;
• that levels of dangerous components in the ingredient have not been adequately controlled through the production process.

It is important to note that the European cosmetic industry maintains a high level of vigilance regarding the quality and safety of cosmetic products. Requiring well-organised ingredient dossiers is part of ensuring such high standards of safety throughout the industry. Incidents from using a cosmetic product and its components can be quickly brought to the attention of the authorities, so they can initiate investigations. With a population of approximately 500 million people using a wide range of products on a daily basis, significant concerns regarding cosmetic ingredients can be detected relatively quickly, and often statistical significance can be established.

Cosmetic ingredients have been categorised into three groups for the purposes of this workbook:

• vegetable oils
• essential oils
• botanical extracts

Underlying the information presented in this dossier is that companies comply with a minimum standard of quality management. At the heart of a quality system is the hazard analysis and critical control point (HACCP) methodology. Although originating from the food industry, the principles of HACCP apply as minimum requirements to processors of cosmetic ingredients. As an industry expectation, all suppliers of cosmetic ingredients need to be operating with HACCP, ideally certified HACCP. In addition to HACCP, the cosmetic industry also requires compliance with the cosmetic ingredient good manufacturing practice (GMP) standard published by the European Federation for Cosmetic Ingredients (EFFCI), which is based on the ISO9001 standard. If you are not implementing HACCP in your company then it is highly recommended that you find out how to do that.

Vegetable oils

All vegetable oils have a similar chemical structure. They are comprised of triglycerides or fatty acids. Different oils have different compositions with regard to their fatty acid profiles. Different profiles perform differently in cosmetics. Hence the fatty acid profile is one of the most important parameters to include in your dossier.

Most pure vegetable oils are inherently safe ingredients when used in cosmetics. Some vegetable oils contain naturally occurring toxic fatty acids, such as erucic acid in rapeseed. In these cases, the toxic fatty acids must be removed prior to human and animal consumption or use in cosmetics, unless the risk is adequately managed.

When vegetable oils are used in cosmetics, the most common problems involve impurities. These impurities are typically proteins found in the oilseed, which remain in the oil due to lower quality processing. Proteins can cause allergic reactions in humans. For some consumers, these allergic reactions can be very serious and even life-threatening. Therefore, European manufacturers typically expect very low levels of protein in oils. Suppliers selling directly to manufacturers will be expected to include an allergen declaration that states the level of protein in each batch.

Essential oils

Essential oils are natural plant extracts. They can contain hundreds of different chemicals. These chemicals are known for their fragrance properties, but also for their anti-bacterial properties and their effects on mood and emotions. Essential oils are powerful chemicals. Some of them can cause very serious health problems. Others can cause adverse skin reactions. Essential oils are more easily flammable than vegetable oils.

Considering these extra hazards, legislators and the cosmetic industry have thoroughly studied essential oils to determine safety levels for their use in cosmetics, as well as the precautions that need to be taken when transporting and handling such powerful chemicals.

Botanical extracts

Botanical extracts typically contain the active components that are used in cosmetics to be able to make claims such as anti-ageing, reduction of wrinkles, hydrating skin and soothing sensitive skin. Botanical extracts require safety and efficacy data.

• Generally speaking, botanical extracts are safe. They are naturally derived and extracted using known solvents. Plants, however, provide not only ingredients for many medicines, but also some of the most potent poisons. Consequently, botanical extracts require validated, reliable safety data. The short- and long-term toxicity risks must be known, so product safety assessors can determine safe levels for use.
• Investing in expensive safety testing can of course be justified more easily when there is good evidence of the cosmetic benefits that a specific concentration in a cosmetic provides over a time period.

What must your dossier contain?

Raw data for all of the above needs to be filed in an ingredient dossier. The data will also be used to prepare the typical technical, safety and promotional documents expected by the industry. As a supplier of cosmetic ingredients, you need to have this dossier ready to help prepare your commercial offer. The dossier itself is a confidential document to be used selectively and carefully with your customers.

The three most important documents in the dossier are:

• Technical Data Sheet (TDS)
• Safety Data Sheet (SDS)
• Product Data Sheet (PDS)

In addition to these data sheets, other supplementary technical information required includes:

• Certificates of Analysis (CoA) of a batch
• certificates of conformity
• allergen declarations

By the time you have prepared the above data sheets and offer your cosmetic ingredient to a European company, you already should have scientifically validated data on the safety and efficacy of the cosmetic ingredient you supply. This data is either derived from your own investigation or it is already in the public domain. If the use of your cosmetic ingredients is well established and known in the European cosmetic industry, the safety and efficacy should also be well understood, hence additional testing will not be required. However, if you want to introduce a new ingredient, then you must have evidence of its safety and efficacy before you can put it on the market.

Preparing a dossier for each ingredient is useful to organise all this data within your company. The ingredient dossier contains all the data for preparing the data sheets, as well as any marketing material. It is a resource for all published and proprietary data on the composition, the safety and efficacy of your ingredient, history of use, production methods and any other relevant information.

In this workbook, we will take you through the steps required to prepare the dossier for your ingredient. For such, we will use templates and other tools, including recommending a specific structure for the dossier itself.

2. Setting up your dossier

The ingredient dossier is the main company resource for all technical, economic, social, environmental data and other information about the ingredient.

The dossier must include the:

• the latest version of all the data sheets, as well as the older, redundant versions, which should be clearly marked;
• certificates of analysis;
• certificates of conformity.

The dossier also contains the ‘raw data’ from which all the data sheets were compiled. It is important for the dossier to be well structured, well organised and to remain updated. This will help you run your business more smoothly. It will save you time when responding to questions from European buyers and when you need to update the data sheets.

A suggested format for the dossier is presented below in Table 2, which can, of course, be adapted to the specific needs of your business.

Table 2: Typical contents of a technical dossier

3. Determining the INCI name for your ingredient

You can skip this step if your ingredient already has an INCI name.

INCI stands for ingredient nomenclature for cosmetic ingredients. All ingredients used in cosmetics need an INCI name. INCI names are based on the botanical names of plant, animal or microbial species, providing a harmonised approach to ingredient labelling and allowing for international recognition.

In the European Union, the glossary of common ingredient names used on product labels uses INCI names. New INCI names can also be used to help promote or launch a new ingredient. It is important to note that INCI registration is not a safety assessment. The INCI application and registration procedure is managed by the Personal Care Products Council (PCPC). If you have a new ingredient, then it is likely that no INCI name has been assigned yet. You will need to contact the PCPC and follow the INCI application procedure including payment of a relatively small fee.

PCPC publishes a dictionary of all INCI names. If you are a PCPC subscriber, you can access this dictionary. If you do not have access to the dictionary, you can contact your local cosmetic industry association to find out if they have access. In the European Union, you can find the registry of many INCI names in the CosIng database. However, CosIng is not a complete list of all known INCI names.

The INCI database is a form of market communication. Once the INCI name is published, then other companies with the same ingredient can use that INCI name too. Therefore, it is advisable to consider first completing all the necessary preparatory steps regarding safety in particular and efficacy, as well as preparing the technical data sheet and safety data sheet before applying for an INCI name. Then, once you have the INCI name, you are ready to start marketing your ingredient immediately.

Do you need to determine the INCI name for your ingredient? This flow chart can help you.

Type of content per product category and document type

Looking at the dossier in more detail, the following table summarises which data and information are required for each of the different categories of cosmetic ingredients. The tables also show where to use the information in the dossier to prepare the TDS, SDS and PDS documents. Examples of the TDS, CoA, SDS and PDS will be provided farther down in the guide.

The data gathering process typically begins with the data sheets and especially the TDS, based on the CoA data, followed by the SDS and PDS. In the table below, the crosses indicate which parameters need to be included in the data sheet. For example, the free fatty acid (FFA) levels are included in the TDS and CoA, but they are not needed in the PDS.

Table 3: Summary of requirements for vegetable oils

Table 4: Summary of requirements for essential oils

Table 5: Summary of requirements for botanical extracts

4. Preparing the Technical Data Sheet (TDS)

The technical data sheet (TDS) is a statement of the technical characteristics of your ingredient. It defines a particular quality that you, as a supplier, guarantees to supply. It also allows your buyers to check whether what they have purchased matches what they agreed to purchase. The TDS is also known as the Product Specification.

The structure of a typical TDS for the different categories of ingredients is shown in the sample below. When the raw data is available from your dossier, it will be a straightforward process to complete the TDS.

Sample TDS for vegetable oils

The following table contains notes about each of the sections in the specification for a vegetable oil.

Table 6: Notes for vegetable oils

Sample TDS for essential oils

Find below information on developing a TDS specifically for essential oils, including making a separate allergen declaration. The following table contains notes on each of the sections in the specification for essential oils.

Table 7: Notes for essential oils

Sample TDS for botanical extracts

The table below gives an overview of the sections to include in the certificate of analysis (see chapter 5) for botanical extracts. This is also buyer dependent.

Table 8: Notes for botanical extracts

5. Preparing the Certificate of Analysis (CoA)

The Certificate of Analysis is used to check whether a batch conforms to the specifications detailed in your TDS. Your buyers may carry out their own analyses of key parameters to check conformance with the TDS.

The parameters in a CoA are the key parameters to be analysed for every batch. You may not always need to test for all the same parameters in the TDS. However, this can also depend on your customer.

6. Preparing the Certificate of Conformity (CoC)

The Certificate of Conformity is a document authorised by the person responsible for quality in the company. This certificate is a signed statement that the Certificate of Analysis for a particular batch of product conforms with the TDS or Specification. Your buyers may also carry out their own analyses of key parameters to check conformance with the TDS.

7. Preparing the Safety Data Sheet (SDS)

A Safety Data Sheet (SDS) is a key document in the overall safety of the supply, handling and use of chemicals. It should help to ensure that those who use chemicals in the workplace do so safely without risk to users or the environment.

European Union legislation on safety data sheets is the regulation on Registration, Evaluation, Authorisation and Registration of Chemicals (REACH) EC 1907/2006, as amended by 453/2010. For the cosmetic industry, all ingredients require a safety data sheet, whether they are classified as dangerous or not. This includes samples, ingredients and chemicals that are exempt from specific chemical registration requirements.

Vegetable oils that are not chemically modified, for example, are exempt from the chemical registration legislation. But for transportation purposes and for sale to a European manufacturer, a vegetable oil requires an SDS.

The development of an SDS requires detailed technical knowledge about your product. The person responsible for preparation of the SDS must understand the implications of their statements in the SDS.

The European Chemicals Agency (ECHA), which oversees the implementation of the REACH legislation, has many guidelines and tools advising on the preparation of safety data sheets. It is recommended that you and the person responsible for the preparation of the SDS study this information if you are not familiar with SDS preparation.

This workbook uses questions to take you through the 16 sections of an SDS. By answering the questions, you develop the most essential information for an SDS. This basic SDS will provide the critical information for safe trade of your product.

The following flowchart is included in the ECHA’s Guidance on the Compilation of Safety Data Sheets, describing the recommended process of collecting and collating the data. However, you will see that the numbering system in the boxes is not sequential. The numbers refer to the order within the SDS, not the order of collection and collation of the data.

Figure 1: SDS compilation flowchart

The SDS must comply with the requirements of the EU REACH Regulation 1907/2006; Annex II as amended by EC 2015/830.

The SDS must follow a 16-section format as follows:

Section 1: Identification of the substance or mixture and of the company or undertaking

Section 2: Hazards identification

Section 3: Composition and information on ingredients

Section 4: First aid measures

Section 5: Firefighting measures

Section 6: Accidental release measures

Section 7: Handling and storage

Section 8: Exposure controls and personal protection

Section 9: Physical and chemical properties

Section 10: Stability and reactivity

Section 11: Toxicological information

Section 12: Ecological information

Section 13: Disposal considerations

Section 14: Transport information

Section 15: Regulatory information

Section 16: Other information

You can use the Classification and Labelling Inventory of the European Chemicals Agency (ECHA) to help you answer the questions below. This database, however, contains only information on registered substances for which other companies have already provided safety data to the ECHA.

An example of an SDS for cardamom oil is provided in the right column of the table below.

Use the following tables to answer all relevant questions for every step of the SDS:

See three actual examples of SDSs for cardamom oil from the following companies:

• Aromantic
• Soap Kitchen
• Merck

8. Preparing the Product Data Sheet (PDS)

The PDS is a marketing tool that combines selected technical information about the product combined with information about the:

• supply chain;
• collection or cultivation of the source materials;
• processors or collectors involved, where this may be of interest to a buyer;
• traditional uses, especially cosmetics or food.

The PDS could also include information about local beauty rituals and traditions of use, where relevant. The PDS may also include photos and references from published documents.

Most suppliers present their PDSs on their corporate websites. It is the primary and first communication vehicle for your ingredient. Technical data sheets are often not published in full on company websites, as they might disclose too much information and help competitors. It is common to present a summary of the key attributes and benefits.

9. Sampling procedures

European buyers normally do not request samples when they first contact suppliers, especially in the case of ingredients that are not used in their fragrances. There is usually a long period where documents are exchanged, including the exchange of confidentiality agreements, before they request a sample.

Buyers of fragrance ingredients can have a different approach. Fragrance is such an important aspect of cosmetics that often fragrance is a primary deciding factor. After a sample is approved then a trial order may be placed.

How much you should send as a sample depends on:

• which type of ingredient;
• why it is requested;
• how it is used in a cosmetic;
• how much it costs.

Typically, you might be asked to send:

• 50 ml of a vegetable oil;
• 10 ml of an essential oil,
• 1–50 g of a botanical extract, depending on the concentration.

Expect your buyer or prospective customer to pay for the sample; however, there is no guarantee that they will pay. It depends on the buyer and it depends on the ingredient. When discussing samples, ask for their international courier account number, if they have one.

Shipping small quantities of dangerous chemicals is very expensive. For that reason, exhibiting at a trade fair is an excellent way to hand over samples of essential oils, for example.

10. Corporate Social Responsibility

Compliance with the principles of corporate social responsibility (CSR) is nowadays a compulsory element of preparation for the international market. Buyers want to ensure their suppliers are compliant with international laws, the laws and regulations where they operate as well as whether vendors are committed to practices meeting their own CSR practices.

Companies are expected to have documents outlining their policies relating to labour standards, health and safety standards, ethical business standards and environmental standards. Without this documentation buyers may lose confidence in you and see you as untrustworthy. Many companies are now going beyond their legal requirements and using standards in their supply chains like Fair Trade and the Union for Ethical Bio Trade (UEBT).

We can consider two broad aspects of corporate social responsibility. The first is the adherence to standards of CSR within the exporter company, meaning the elements of social responsibility that are under direct control of the owners of the company. The second aspect is the social responsibility within the supply chain. Of course, expecting your suppliers to adopt the same standards of social responsibility as yours, as their customer, is a logical expectation, especially in the eyes of your customers and their customers.

At the same time, it is possible to incorporate other additional aspects of social responsibility within your supply chain that go beyond the conventional aspects of corporate responsibility, such as Fair Trade and Biodiversity Sustainability.

Company level

SEDEX

Many buyers in Europe and around the world subscribe to SEDEX. In our surveys of European companies all have said that working with suppliers who also subscribe to SEDEX is an advantage.

SEDEX is a platform that allows you to share information about your responsible sourcing business with your buyers and potential buyers. It involves completing a self-assessment questionnaire and adding audit reports and certifications. SEDEX does not offer a set standard, it is independent from any single standard or methodology. There is a membership fee of approximately £100 per year if you are a supplier. There are other subscriptions for buyers and other companies further downstream. Using SEDEX will also help suppliers prepare for most CSR questions from buyers, for example, in buyer questionnaires, as mentioned below.

The SEDEX self-assessment questionnaire cover topics in the following four categories:

• Labour
• Health and Safety
• Business Ethics
• Environment

Figure 2: SEDEX self-assessment questionnaire topics, accessible with SEDEX membership:

For each category there are series of questions. See Figure 3 below, for example, for the category of Labour.

Figure 3: Example Labour category questions from the SEDEX self-assessment questionnaire:

Figure 4: Example extract from SEDEX self-assessment questionnaire:

It is also possible to upload external audits and other documents. The SEDEX self-assessment questionnaire is available in 15 languages.

If a buyer who also subscribes to SEDEX is interested in seeing your SEDEX profile, the buyer will request your SEDEX reference number. Apart from the profile, your information is confidential and not available outside the SEDEX system. More detailed information about SEDEX is available from the SEDEX website and in the SEDEX workbook.

Supply chain

The standard aspects of corporate social responsibility in your supply chain are equally important to your suppliers. Your customers expect not to find child labour, for example, at your factory nor anywhere in your supply chain. Therefore, applying the SEDEX questionnaire to your own suppliers is a very good practice.

Traceability

Traceability has always been important, but has taken on a new level of significance under the European cosmetics regulation. Increased interest in certification is driven by the need for traceability. Certification with external standards, whether organic, natural, fair trade, fair wild or biodiversity, provide traceability in addition to the requirements of the particular standard. In particular, when companies invest so much in promoting specific ingredients from specific sources, they need to have complete confidence in the origin.

External standards

Some buyers require external standards as well as a company’s own documentation on CSR. External standards require a third party to independently verify CSR policies and often have fees associated with them. External standards provide traceability and transparency along the whole supply chain. Some standards, such as Fair Trade and organic certification, require every link in the supply chain to be certified if a company wishes to use their logo. These companies will not source their ingredients from you if you do not have this certification.

Fair Trade

Fair trade certifications are offered by a number of different accreditation services. Common across all certifications for fair trade is ensuring that producers receive fair prices and a focus on social, economic and environmental development for the producers. The definition of fair trade differs depending on the fair-trade certifier. The following certifying bodies offer fair trade certification: Ecocert/IMO, Control Union and Fairtrade International.

Biodiversity: UEBT Standard

The Union for Ethical Bio Trade (UEBT) standard  focuses on sourcing with respect to people and biodiversity in the natural ingredients for sectors such as cosmetics, pharmaceuticals and food. The UEBT standard is built on BioTrade principles and criteria developed by the UNCTAD BioTrade initiative.

Topics of the UEBT Standard

Figure 5: Topics of the UEBT Standard

Natural and Organic standards

Cosmos

Cosmos is a standard applied to cosmetic products that are marketed as natural or organic. The standard covers all aspects of sourcing, manufacture, marketing and control of cosmetic products. Products that are certified by Cosmos must be formulated using only ingredients that the standard allows. Raw materials must either be certified or approved — certified ingredients have organic content, approved raw materials are non-organic.

To certify your ingredients with organic content you need to apply to an authorised certification body, audited before you receive your certification. To gain approval for your non-organic content ingredients, you must apply to an authorised body which will send you a raw materials questionnaire to be verified before granting approval. Once certified or approved your ingredients will appear on the databases for certified ingredients or approved raw materials.

NATRUE

NATRUE is a not-for-profit association based in Belgium that has developed standards for natural cosmetics, natural cosmetics with an organic portion and organic cosmetics. NATRUE has classified ingredients used in cosmetics into three basic types: natural, derived natural and nature identical ingredients. Nothing artificial or man-made is allowed in NATRUE certified cosmetics. A manufacturing company that aims to obtain NATRUE certification for its products can refer to the list of compliant ingredients on the NATURE raw materials database. Suppliers of raw materials seeking to obtain NATRUE certification can contact NATRUE for information on how to register ingredients on this database.

Organic

Organic certification involves a set of production standards for growing, storing, processing, packaging and shipping that generally avoids synthetic chemical inputs, irradiation, genetically modified seed, farmland that has received chemical inputs within a certain amount of time. Organic certification also generally requires keeping detailed records on production and sales, strict physical separation of organic products from non-certified products and undergoing periodic on-site inspections. In Europe, where organic is a legally defined term, labelling food organic and importing organic products are strictly controlled.

Organic products imported from non-European countries can only be distributed in the European market if they are produced and inspected under conditions that are identical or equivalent to the standards of European producers. You can obtain organic certification from a number of different accrediting bodies. European organic legislation is published under the following:

Council Regulation (EC) No 834/2007

There is no specific legislation for organic cosmetics. The private standards developed by COSMOS and NATRUE, for example, use organic food legislation as a reference for an organic quality in cosmetics.

IS0 26000

ISO 26000:2010 is intended to assist organisations in contributing to sustainable development. It cannot be certified like other ISO standards. This standard provides guidance on the underlying principles of social responsibility, the core subjects of social responsibility, recognising social responsibility as an organisation, engaging stakeholders and integrating social responsibility into an organisation.

Figure 6: The core subjects and issues of social responsibility

United Nations Global Compact

The United Nations Global Compact is a global corporate sustainability initiative that supports companies to do business responsibly and take strategic action to develop broader societal goals, such as the United Nations Sustainable Development Goals. The Global Compact has ten principles based around human rights, labour, the environment and anti-corruption. Companies can become signatories or participants in the Compact by preparing a Letter of Commitment. The Letter of Commitment contains: a statement expressing support for the compact, a description of the practical actions that the company has taken or plans to take to implement the ten principles of the compact and a measurement of the outcomes, i.e. the degree to which the targets or performance indicators were met. To be a signatory, companies must pay an annual contribution depending on annual sales revenues. Companies with average sales revenues under 25 million US dollars are asked to contact their Local Network to discover if a contribution applies. To be a participant, annual contribution starts at 1,250 US dollars for companies with annual sales revenue under 25 million US dollars.

The UN Global Compact is not a performance or assessment tool. It does not provide a seal of approval, nor does it make judgments on performance. Participants are expected to publish in their annual report or similar corporate report (e.g. sustainability report) a description of the ways in which they are supporting the UN Global Compact and its ten principles. This is known as the Communication on Progress. The UN Global Compact believes that this sort of openness and transparency encourages improved practices by participants.

The Communication on Progress (COP) is frequently the most visible expression of a participant's commitment to the Global Compact and its principles. According to the policy, failure to issue a COP will change a participant’s status to non-communicating and can eventually lead to the expulsion of the participant. You can find out more about how to participate in the Global Compact here.

The United Nations Sustainable Development Goals

Adopted by all United Nations Member States in 2015, the 2030 Agenda for Sustainable Development provides a shared blueprint for peace and prosperity for people and the planet, now and into the future. At its heart are the 17 Sustainable Development Goals (SDGs), which are an urgent call for action by all countries in a global partnership. They recognize that ending poverty and other deprivations must go hand in hand with strategies that improve health and education, reduce inequality and spur economic growth while tackling climate change and working to preserve the world’s oceans and forests.

The SDGs result from an inclusive process that has governments involving businesses, civil society and individuals. Fulfilling these ambitions will take an unprecedented effort by all sectors in society. Business has an important role in the process.

Companies are encouraged to do their part in achieving the SDGs under the commitment towards corporate social responsibility in many ways. Click on this link for more information about how companies can contribute to the Sustainable Development Goals.

Figure 7: The United Nations Sustainable Development Goals

Company Questionnaires

The majority of all companies send supplier questionnaires to all new and potential suppliers. Please find below an example of one such questionnaire. In many cases, using SEDEX will prepare you to answer many of the questions that buyers ask.

These questionnaires usually request the following information about your company. At the end of it, a declaration must be signed by a senior representative of the company.

Company details

• Quality
• Regulatory
• Manufacturing
• Health and Safety
• Social Responsibility
• Environment
• Declaration

EXAMPLE BASIC SELF-AUDIT FORM

Please complete in full and return this form to the requested

1. COMPANY DETAILS

1.  
   1. Company Name and Address

1.  
   2. Manufacturing site(s) and address

If more than one address, please attach a list of all sites specifying products made at each location

1.  
   3. Is production of any of your materials outsourced to another manufacturer?

If yes, please provide information

1.  
   1.  
      1. Production capacity of each product to be supplied (in tonnes)

1.4          Business type

1.5          Please confirm your role in the supply chain

1.6          Year business commenced

1.7          Please provide a copy of your company organogram

1.8          Key personnel contacts

                Please provide name, job title, contact number and email address

1.9          Emergency 24-hour contact: name, company name and contact number

1.10       Do you have current sales in Europe or do you work with a distributor in Europe?

                If yes, please provide details

2. QUALITY

1.  
   1. Are you ISO-9001 certified?

Please attach certificate and contents page of your Quality Management System, then proceed to section 3. If no, please complete section 2

1.  
   2. Do you have a documented Quality Management System? If yes, how often is it reviewed?

Please include a copy of the index page or Standard Operating Procedure (SOP) and outline content of SOP

2.3          What is the format and frequency of internal audits?

                If referring to a SOP, please provide a copy or outline of content of SOP

2.4          What, if any, quality management tools are being used to continuously improve site performance?

                If referring to a SOP, please provide a copy or outline of content of SOP

2.5          What procedures are in place for dealing with customer complaints?

                If referring to a SOP, please provide a copy or outline of content of SOP

2.6          How is complaint and feedback information used to improve processes and product quality?

                If referring to a SOP, please provide a copy or outline of content of SOP

2.7          How often are customer and internal complaint trends reviewed?

                If referring to a SOP, please provide a copy or outline of content of SOP

3. REGULATORY

3.1          How do you keep up to date and compliant with applicable EU legislation?

3.2          Has your company received any regulatory actions in the last three years?

                If yes, please provide details and list corrective actions you have taken

3.3          Please attach a European SDS/MSDS, typical specification and a CoA for a product.

3.4          If you are able to provide SDSs/MSDSs in other European languages, please list those that are available.

3.5          Please provide information or a status on the REACH status of your company and products.

3.6          How are products tested and verified to ensure compliance with applicable regulatory requirements and

performance standards?

                If referring to a SOP, please provide a copy or outline of content of SOP

4. SITE AND MANUFACTURING

1.  
   1. How do you approve your raw material suppliers?

If referring to a SOP, please provide a copy or outline of content of SOP

4.2          Do you hold specifications agreed with your suppliers for all raw materials purchased?

4.3          Do you have a procedure to check if incoming raw materials meet specifications?

                If yes, please provide information. If referring to a SOP, please provide a copy or outline of SOP

4.4          Are handwashing facilities located at each entrance to production and packaging areas?

4.5          What checks and procedures are in place to ensure that all machinery and tools are in good condition, adequately maintained and fit for purpose?

                If referring to a SOP, please provide a copy or outline of SOP

4.6          Are all critical items of plant equipment subject to scheduled and traceable calibration?

                If referring to a SOP, please provide a copy or outline of SOP

4.7          Do you use an in-house or contract laboratory to test products? If yes, are they formally accredited, for example, by UKAS, CLAD or LabCred?

                If yes, please provide information

4.8          Do you quality control check each batch to specification?

                If yes, please provide information. If referring to a SOP, please provide a copy or outline of SOP

4.9          Do production lines include:

4.10        Do you have systems in place to retain samples of all product batches and to verify the shelf life of products?

                If yes, please provide information. If referring to a SOP, please provide a copy or outline of SOP

4.11       Do you have any control procedures in place for the following:

4.11.1    Allergens

                If yes, please provide information

4.11.2    Cross contamination

                If yes, please provide information

4.11.3    Foreign bodies

                If yes, please provide information

4.11.4    Stock segregation

                If yes, please provide information

4.12        What checks and controls are in place to ensure finished products are adequately packaged and correctly labelled at the point of dispatch?

                If referring to a SOP, please provide a copy or outline of SOP

4.13       What is the cleaning schedule for:

4.13.1    Warehouse

4.13.2    Manufacturing area

4.13.3    Packing area

4.14       Do you have a formal recall procedure?

If yes, please provide information. If referring to a SOP, please provide a copy or outline of SOP

4.15        Describe contingency plans in case of an event which prevents manufacture of products and could affect supply.

5. HEALTH AND SAFETY

5.1          Is there a communicated and measurable health and safety policy in place?

If yes, please provide information. If referring to a SOP, please provide a copy or outline of SOP

5.2          Do you have formal risk assessments such as HACCP systems in place?

                Hazard analysis and critical control points, or HACCP, is a systematic approach to food safety and

pharmaceutical safety that identifies physical, allergenic, chemical and biological hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level.

                Please also provide a flowchart

If yes to the questions 5.1 and 5.2, please continue to section 6. If no, please complete the remaining questions in this section

5.3          What is the procedure for reporting accidents that occur on site?

If referring to a SOP, please provide a copy or outline of SOP

5.4          What procedures and controls are in place to manage major accidents, emergencies or breaches of legislation?

If referring to a SOP, please provide a copy or outline of SOP

5.5          What first-aid and medical facilities are available on site?

5.6          Are fire extinguishers frequently serviced, readily available? Have workers been trained in their use?

5.7          How often are fire evacuation drills conducted and what details are recorded?

5.8          How is the wearing of personal protective equipment (PPE) controlled and enforced on site?

5.9          Is the site covered with a pest control contract?

                Please provide details on level of cover and attach contract

6. ETHICS

6.1          Are you registered with SEDEX?

SEDEX is a not-for-profit membership organization dedicated to driving improvements in ethical and responsible business practices in global supply chains.

                If yes, please provide registration number

6.2          Do you have a corporate social responsibility policy prohibiting the use of:

6.2.1      Child labour

6.2.2      Slavery

6.2.3      Payment or acceptance of bribes or inducements

6.3          Do workers have freedom of association?

6.4          Do you have SA8000 certification?

                Please attach certificate

6.5          Do you have training systems and records of all employee training?

                If yes, please provide information. If referring to a SOP, please provide a copy or outline of SOP

7. ENVIRONMENT

1.  
   1. Do you hold an ISO-14100 certification?

If yes, please attach certificate and policy, then proceed to signature page. If no, please complete questions 7.2 and 7.3

7.2          Is there a communicated and measurable environmental policy in place?

                If yes, please provide information

7.3          What are the company’s environmental objectives?

I hereby confirm that all information provided is accurate and agree to immediately notify you in writing of any change to the above details:

Authorised signature: _________________________________________

Name: ______________________________________________________

Position: ____________________________________________________

Email: ______________________________________________________

Telephone number: ___________________________________________

Date: _______________________________________________________

Please review our market information disclaimer.