1. What is Material Safety Data Sheet?

  The Material Safety Data Sheet is widely used, very effective way of  providing informations concerning substances and mixtures in European Union, which became integral part of system within The European Parliament and the Council Regulation (EC) No 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency and modified Directive 1999/45/EC and rescinded Council Regulation (EEC) No 793/93, Comission Regulation (EC)No 1488/94, Council Directive 76/769/EEC and Council Directives 91/155/ EEC, 93/67/ EEC, 93/105/EC and 2000/21/EC. It concern only dangerous substances contained in a preparation. It doesn’t give us any information about a preparation, which was considered harmless for environment and human life and health. Material Safety Data Sheet enumerate only these components of the preparation, which was considered dangerous.

2. What informations from Material Safety Data Sheet we can find out?

  Material Safety Data Sheet inform about procedures for correctly use and storage dangerous mixtures and substances. This regulation include ncessary informations, as: physicochemical properties (melting point, boiling point, ignition point etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective measures and procedure in case of getting to enviroment. Material Safety Data Sheet supplied use only for information aims.

3. Does Material Safety Data Sheet include informations about the composition of a preparation?

  There’s no informations in Material Safety Data Sheet about the full composition of the preparation. In 3. section of Material Safety Data Sheet we can find some informations about dangerous substance contained in mixture.

4. How to find the composition of a preparation?

  The composition is located on the back label on cosmetic product.

5. How cosmetic is composed on a label?

The list of components defined in accordance to names accepted by International Nomenclature of Cosmetics Ingredients (INCI), preceded by expression “ingredients”, includes:

     - components in decreasing order according to mass in the moment of their adding, but components at a concentration less than 1% can be list in optional order after components at a concentration more than 1%,

     - aromatic compositions called as “aroma” or other apropriate name accepted by INCI, including substances they are consisted of, which mention the list referred to in article 15 paragraph 3 point 2 and these substances have to be enumerate no matter what function they have in cosmetic,

     - numbers of pigments, which can be enumerate after other components in optional order, according to their numbers characterized in the list of pigments allowed to use in cosmetics; if cosmetics are selling in many different tones,  allowable is to enumerate all pigments after signed them with the graphic symbol „+/–”.

6. Which acts and regulations regulate cosmetic industry?

 

  • THE ACT of 30 March 2001 on cosmetics.
  • COUNCIL DIRECTIVE of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC)
  • REGULATION OF THE EUROPEAN PARLIAMENT AND THE COUNCIL (EC) No 1223/2009 of 30 November 2009 on cosmetic products

 

7. What are components of the Dossier for cosmetic products?

     - the qualitative and quantitative composition of a cosmetic, if it’s aromatic composition – its name or number and supplier’s name and adress,
     - physicochemical and microbiological specifications of materials and final products and criteria of microbiological cleaning’s control of cosmetic,
     - the description of  production’s methods according to good production practice,
     - the evaluation of cosmetic’s influence on the human health’s safety considering toxicological profile of components, their chemical structure and the grade of contact with human body and also name and adress person in charge of this evaluation; the evaluation consider quality of places, where cosmetics will be used or target group, which will use the product, particularly cosmetics allocated only to external intimate hygiene and for children under 3. years of age,
    - the existing data about adverse effects for human health, rised as a result of using cosmetic,
    - documented results of research about cosmetic’s action, if it is necessary because of reactions to cosmetic, which were declared,
    - the data concerning all animal tests made by producer, his representative or suppliers while rating cosmetic’s or its component influence on human health; this requirement apply to tests, which are obligatory to fulfil the conditions of countries from beyond the European Union.

8. What is my status? Am I producer (manufacturer) or distributor??

 According to Act (no. 1223/2009 EC) art. 2  definitions are:

„distributor”  - means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes available a cosmetic product on the Community market.
„producer”  - means any natural or legal person, who manufacturers a cosmetic product or commisions product design or manufacturer and introduce that product on market under his own name or trademark.

  According to Act (no. 1223/2009 EC):  art.4 point 6:

Distributor is responsible person, if introduces cosmetic product on market under his own name or trademark or  changes product, which is already on market, in way that can impact on compliance with the applicable requirements.
If company sells cosmetic under it's own brand or trademark gains status of producer, what results taking full responsibility for product and necessity of making research and  adapt the product / cosmetic to requirements of EU and Act no. 1223/2009 EC.

9. Important changes after 11 July 2013

On 22 December 2009 in Official Journal of the European Union were published  opublikowane zostało Regulation of the European Parliament and of the Council (No. 1223/2009 EC) on cosmetic products. It will come into force on 11 July 2013, replacing the same cosmetics directive.

  New regulation imposes a number of obligations on traders who place on the market cosmetics, as:

a.  mandatory registration entrepreneur in ECAS base (European Commission Authentication System);
b.  making notifications for cosmetic products to the Commission by electronic way via CPNP (Cosmetic Products Notification Portal);
c.   introducing updates / corrections to the notified cosmetic products;
d.   obligation to production in accordance with GMP;
e.   obligation of traceability – what means tracking of flow and origin of the product and components.

10. PN-EN ISO 22716

  Regulation of the European Parliament and Council Regulation (EC) No 1233/2009/WE dated. 30.11.2009 concerning cosmetic products requires manufacturers of cosmetic products obligation to production of cosmetics in accordance with the Good Manufacturing Practices. In order to facilitate the implementation the principles of Good Manufacturing Practices (GMP) developed and published the standard PN-EN ISO 22716:2009 "Cosmetics. Good Manufacturing Practices (GMP). Guide of Good Manufacturing Practices", which contains requirements for the production, control, storage and transportation of cosmetic products. The standard has been notified as a harmonized standard for Good Manufacturing Practices in the beauty industry. The implementation of Good Manufacturing Practices (GMP) will be mandatory from 11 July 2013.

11. Does Silcare® company fulfil the requirements of regulation?

  Since 2009, our company has adopted a policy of complying with the requirements of the new Regulation (1233/2009/WE). The years 2009-2013 were devoted to constant adaptation of production to the requirements of the Act. The following steps have been taken:

  - purchase of the PN-EN ISO 22716 (payablestandard acquired in the Polish Committee for Standardization)

  - collect and supplement the "traceability" documentation (the origin of the product and components)

  - creating a complete Dossier of producing cosmeticsw

  - preparing documentation of Good Manufacturing Practises (GMP)

  - registration in ECAS bas.

12. How to create a sub-organization?

All necessary pieces of information are in the manual of CPNP (Cosmetic Products Notification Portal) in the following subsection:

1.3.3.3 Delegation mechanisms in SAAS.

Responsible person has the right to decide on delegating its product notification to sub-organizations thanks to the mechanism of sub-delegation introduced in SAAS. This function is very useful especially when these notifications are to be made by another entity ( for instance by a consultant) on behalf o a responsible person or when a responsible person wants to divide its notifications according to the brand and type of products.

The organization structure in SAAS is as following:

- At level 1 there is a ‘parent organization’. It is always a responsible person.

- Below the level 1 there might be sub-organizations connected with a responsible person. These sub-organizations have the right to notify products into CPNP portal on behalf of a responsible person. The notifications made by a user belonging to a given sub-organization are visible and editable for all users of this sub-organization. These notifications are also visible (but not editable) for a responsible person.

How to create a sub-organization in SAAS?

There are two possibilities of creating a sub-organization in SAAS:

- When a user makes a request for access to CPNP he/she can select an existing sub-organization or can create a new one. A local administrator of parent organization will have to accept or reject the creation of new sub-organization and any access to this sub-organization.

- A local administrator of organization can also create new sub-organizations by selecting ‘ Create new’.
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13. What does MEHQ mean?

  MEHQ  stands for  a Hydroquinone methylether (methyl ether of hydroquinone/ mequinol), CAS number 150-76-5. Its synonyms are as follows: p-Hydroxyanisole; p-Methoxyphenol; Hydroquinone monomethyl ether; Mequinol.
 
  It is used as an inhibitor of vinyl and acrylic monomers especially in pure products and as an antioxidant . it is also used as a stabilizer for inhibiting the formation of peroxide in the ethers, chlorinated hydrocarbons and  ethylocellulose.  It can be an intermediate used for the preparation of other stabilizers, dyes, pharmaceuticals and plasticizers. A more complete description of this compound can be found:

http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.details&id=28110

  According to the current Regulation of European Parliament and Council (EC) no. 1223/2009 from 30th of November 2009 concerning cosmetic products, MEHQ compound is acceptable in the manufacture of cosmetic products and is subjected to certain restrictions. It can be used in some sets for fake nails. A maximum concentration in ready-for-use product is 0.02% (200ppm), and the following information has to be visible on the packaging: For professional use only. Avoid contact with eyes. Read carefully the instructions of use.

The regulation that we refer to can be found in English and Polish languages:

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:pl:PDF

The report on this issue has been drawn by SCCS (Scientific Committee on Consumer Safety).

http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out167_en.pdf

  It is a Scientific Committee on Consumer Safety, which provides opinions and reports on threats for health and safety (chemical, biological, mechanical and other physical dangers), on non-food consumer products (eg. cosmetic products and their ingredients, toys, textiles, clothing, personal care products and household appliances) and services (eg. tattooing, artificial tanning). More information about this Committee can be found:

http://ec.europa.eu/health/scientific_committees/consumer_safety/

  Scientific Committee on Consumer Safety confirms the safety of using MEHQ compound at a concentration of 200ppm (0.02%) in a finished cosmetic product (in the system for fake nails).

  Silcare products are characterized by high purity containing 100-200ppm of MEHQ, which is less than 0.02% (200ppm), these are just trace amounts in our ready-for-use nail  products. What is more important, these products are safe for human health and in accordance with applicable regulations.

  Ppm (parts per million) is a way of expressing the concentration of very diluted solutions of chemical compounds. The concentration is a derivative of the mole fraction and it defines how many molecules of a chemical compound fall to 1million molecules of  solution. For more information:

http://pl.wikipedia.org/wiki/Ppm

1 ppm = 1/106 ⇒ 10-4 %
1% = 1/100
1ppm = 1/1000000, so  1ppm – 0.0001 %
200ppm = 0,02 %

The calculator published on the website can be very helpful in calculating.

14. Is it possible to have invariant formulations?

„Must-have” regulations.

  Habit is a second nature. It is an automatic activity, which performance comes from the need that we feel. We get accustomed to people, things and…cosmetics. EU directives clearly define the obligations of entrepreneurs who place cosmetics on the market. This refers to the identity, common functions, restrictions with regard to chemical ingredients, and their presentation on the label. New regulations which appear successfully, prevent cosmetic companies from developing a stable, uniform formula on which the production process would be based. It is impossible to create cosmetics of the same name and of the same composition throughout the whole period of enterprise functioning.

  Regulation of the European Parliament and Council (EC) No 1223/2009 from 30th of November 2009 relates to the significant changes concerning cosmetic products. A number of fundamental changes have been introduced with respect to the cosmetic production and cosmetic marketing. The definition layer of key terms such as ‘marketing’ or ‘producer’ also has been changed. The category of ‘responsible person’ has appeared as well, to whom the largest part of production and marketing requirements has been assigned. Additionally, the term ‘distributor’ has been defined. The requirements of this group has been clearly set out, and the new arrangements concerning the content placed on the cosmetics’ labels have been introduced.  According to the EU law, the composition of every cosmetic product has to be declared with respect to INCI ( International Nomenclature of Cosmetic Ingredients). The ingredients are placed in descending order according to their weight.

  Since 2009, Silcare company adopted the policy of complying with a new regulation (1233/2009/WE). The years 2009-2013 were devoted to lifelong production adaptation to the regulation requirements. The following steps have been taken:
 

  • the purchase of PN-EN ISO 22716 standard ( payable standard acquired in the Polish Committee of Standardization)
  • the collection and fulfillment of ‘traceability’ documentation ( product and its components origin)
  • the creation of complete Dossier of produced cosmetics
  • the preparation of Good Manufacturing Practices (GMP) documentation
  • ECAS registration

  Another regulation that hinders cosmetic companies from functioning on the market is the EU Regulation No. 618/2012 from 10th of July 2012. It refers to the absolute prohibition on the use of TPO in the industry. This is one out of six photo-initiators which Silcare specialists use for producing gels. Trimethylbenzoyl Diphenylphosphine Oxide is responsible for initiating the process of curing under UV lamps.

  Taking into account significant changes, we cannot forget about the regulation which is concerned with MEHQ component (Hydroquinone Methylether). European Parliament imposed the restriction on the concentration of this component used in the products for nail care to a dose of 0.02% (200ppm).

  But this is not the end yet. The year 2014 will bring other obstacles. Since 30.10.2014, the absolute prohibition on the use of Isobutylparaben is going to be introduced. These changes are regulated by the Regulation No. 358/2014 from 9th of April 2014. Isobutylparaben is a preservative substance, which prevents the development and survival of microorganisms during the product storage.  It also protects the product against bacterial infection, which may occur while daily use of this product.

  On behalf of our customers we design and create products from A to Z. These are our own technical, design formulas and solutions. We do not imitate other patterns available already on the market. For many years we have been investing in the development of our experienced staff, and in the production lines. All these things are to create from start to finish a professional product for your hair, body and nails, depending on the needs of our customers. Today, our staff consists of more than 100 experienced people in their tasks. We also choose the packaging design for you. We possess a wide range of glass, lacquered-type packages and cosmetic jars such as PP/PS/SAN. In our warehouse you will also find many bottles of different capacities made of aluminum, polypropylene or HDPE material.

  We can boast about hundreds of successful order realizations not only in our country but also abroad.  We produce equally large, long series of cosmetic products for medium-sized businesses, as well as short series for smaller companies. Every order, no matter if it is big or small, is considered individually. However, if we are talking about the changes that are implemented by the EU regulations, we feel absolutely obliged to comply with them. This prevents us from developing a stable and uniform formula, on which the manufacturing process of Silcare cosmetics would be based.
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15. The producer’s position of Silcare- Florence in light of 1223/2009 Regulation.

  This regulation is concerned only with cosmetic products, not including remedial products, medicinal products and biocidal products.  The demarcation of this border stems especially from the detailed definition of cosmetic products, that refers not only to the place of their application but also to the purpose of their application. (7) The assessment, whether a given product is a cosmetic product, has to be made on the basis of individual product’s assessment, taking into account all its features.  Cosmetic products may include creams, emulsions, liquids, gels and skin oils, face masks, tinted foundations (liquids, pastes, powders), make-up powders, bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, eau de toilette, eau de cologne,  bath and shower means (salts, foams, oils, gels), depilatories, deodorants and anti-perspirants, hair dyes, products for hair waving, hair straightening and hair fixing, products for hair styling, products for hair washing (liquids, powders, shampoos), hair conditioners (liquids, creams, oils), product for hair styling (liquids, hair spray, brilliantines), shaving products (creams, foams, liquids), make-up and make-up removal products, products for lips, products for teeth and oral cavity care, products for nail care and nail painting, products for intimate hygiene, sunbathing products, self-tanning products, products for skin lightening and anti-wrinkles products. (11) To clearly assess the responsibility range, every cosmetic product should be assigned to the person responsible for this product, whose legal address is located on the territory of the Community.  (13) It is necessary to determine certain conditions under which a distributor is to be perceived as a responsible person. (14) The definition of ‘distributor’ stands for all natural legal persons in wholesale trade, as well as retailers selling their products directly to customers. So the distributor’s responsibilities should be adapted to the adequate role and to the type of business activity of these persons. (17) In order to supervise the market effectively, the product’s documentation should be available under the same address in the Community for the proper authority of the Member State which possess this documentation.  (22) In order to supervise the market effectively, certain authorities should be provided with information concerning cosmetic products that are placed on the market.

  (24) In order to minimize administrative liabilities, submitted information should be passed to the right authorities, poison control centers and related persons in the Community, using an electronic interface.

Will the Online Cosmetic Products Notification Portal replace KSIOK?


“ Cosmetic regulation has introduced the unification of notifying cosmetic in the European Union.  Since 11th of January 2012 persons responsible for a given cosmetic product have a possibility to submit information referred to in the Article 13 of Regulation No 1223/2009 to the Online Cosmetic Products Notification Portal (CPNP). CPNP portal is an electronic system created for notifying information about a given cosmetic that is placed on the market or made available on the European market. Year-and-a-half period of portal functioning is just a preparation for 11th of July 2013 when notifying products in this portal will become obligatory.”

Quotation from portal: biotechnologia.pl

Article 13/ 1223/2009 Regulation            Notifying:

  1. Before placing a cosmetic product on the market, the responsible person has to electronically provide  European Commission with the following information:
  1. Cosmetic product’s category, its name or names enabling unequivocal identification;
  2. Name and surname (company) of responsible person and the address under which the product documentation is available;
  3. Country of origin (in case of importing);
  4. Member State where the product will be placed on the market;
  5. Contact data of natural legal person, in case of need for contacting
Article 2/ 1223/2009 Regulation      Definitions:
  1. For the purposes of this Regulation, the following definitions are applied:
  1. ‘ cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view to exclusively or mainly to cleaning them, perfuming them ,changing their appearance, protecting them , keeping them in good condition or correcting body odours.
  2. ‘producer’ means any legal or natural persons that produce the product or instruct others to design or produce a given product, which they later place on the market under their own name or trademark;
  3. ‘distributor’ means any legal or natural person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market.
  4. ‘making available on the market’ means any supply of a cosmetic product for distribution, consumption, or use on the Community market in the course of a commercial activity, whether in return for payment of free of charge.
  5. ‘placing on the market’ means the first making available of a cosmetic product  on the Community market.
Article 4/1223/2009 Regulation    Responsible person:

6.  The distributor shall be the responsible person where he places a cosmetic product on the market under his own name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.

  Silcare-Florence company has notified In CPNP portal all products that are placed on the market. These cosmetics have been notified under the trade name and with the label just like they look in the reality eg. Base One Clear Gel 5g has been notified in CPNP in the following form:




  As the responsible person we mark on the labels of cosmetic  products that we place on the market and notify in CPNP portal the address, under which the documentation of a notified product, known as product Dossier can be found.

  Silcare-Florence company do not possess any notifications and documentations of cosmetics placed on the market under the trade names of our customers.

  We recommend to become familiar with the full text of 1223/2009 Regulation and to refer to its provisions.





 

16. Patterns of correct labels.

The producer’s position of Silcare- Florence with regard to the responsible person in light of 1223/2009 Regulation.
 
  Regulation of the European Parliament and Council (EC) No 1223/2009 from 30th of November 2009 concerned with cosmetic products dictates that the information about the responsible person has to be placed on the label of a given cosmetic product.

Silcare's label

The label includes Silcare company’s data (name, address) acting as a producer on the label (at the same time being the  RESPONSIBLE PERSON)
 
Under no circumstances can the label be changed:
 

  • Product’s name
  • Label’s color
  • Label’s size
  • Graphic contents



Customer's label (private label)

The label includes Customer’s data, who sells a given product under his own brand, with his own logo and own name different from the name of Silcare’s product (in this way becoming the RESPOSNIBLE PERSON):
 

  • In this case the Customer (full company’s name, address, contact data) is placed on the label as the RESPONSIBLE PERSON= DISTRIBUTOR
  • According to Art. 4 of Regulation No 1223/2009 paragraph. 6.