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and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency and modified Directive 1999/45/EC and rescinded Council Regulation (EEC) No 793/93, Comission Regulation (EC)No 1488/94, Council Directive 76/769/EEC and Council Directives 91/155/ EEC, 93/67/ EEC, 93/105/EC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 a producer or a 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 11th of 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’.

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.

15. Die Stellungnahme der Hersteller Silcare ®bezüglich die Verordnung 1223/09.

Die Stellungnahme der Hersteller Silcare ®bezüglich die Verordnung 1223/09.

  Diese Verordnung betrifft nur die kosmetische Produkten, nicht die Arzneimittels, Medizinprodukte, Biozide. Unterschied ergibt sich aus einer detaillierten Definition des Produkts, die sowohl für ihre Anwendungsbereiche, sowie die Anwendungsziel gilt. Beurteilung, ob ein Erzeugnis ein kosmetisches Mittel ist,  auf der Grundlage einer individuellen Bewertung des Produktes unter Berücksichtigung aller seiner Eigenschaften festgestellt werden soll. Kosmetische Produkten sind: Cremes, Emulsionen, Lotionen, Gele und Öle für die Haut, Kosmetische Mittel können sein:   getönte Grundlagen (Flüssigkeiten, Pasten, Pulver), Pulver für Make –up, Pulver für Bad, hygienischen Pulvern, Toilettenseife, Deoseifen, Parfüm, Toilettenwasser, Eau de Toilette, Eau de Cologne, Bad und Duschemittels ( Salze, Schäume, Öle, Gele), Deodorants, Haarentfernungsmittel, Antitranspirantien, Haarfarbemittel, die Produkten für Dauerwelle, Produkte für Styling und Festigung der Haare, Produkte für die Haarwäsche, ( Flüssigkeiten, Pulver, Schampoo ), Haar-Conditioner ( Flüssigkeiten,  Cremes, Olive), Produkte für Haarstyling ( Flüssigkeiten, Haarspray, Brillantine), Produkten für  Rasur (Cremes, Schäume, Flüssigkeiten), Produkten für Make-up und Abschminken  und Lippen, Produkte zur Pflege der Zähne und der Mundhöhle, Produkte für Nagelpflege und lackieren die Nägel, Produkte für die Intimpflege, Produkte für Sonnenbad, die Selbstbraunern, Haut-erhellen-und Anti-Falten Produkte. Um die Verantwortlichkeit klar zu definieren, jedes kosmetische Mittel soll einer verantwortliche Person, die ein Sitz auf der Gemeinschaftsgebiet hat,  zugeordnet werden. Es ist notwendig die Bedingungen unter denen der Händler als verantwortliche Person zu sehen ist, festzustellen. Definition der Händler umfasst alle juristische und natürliche Personen, die im Großhandel sowie in Einzelhandel direkt an der Konsument  verkaufen.  Pflichten der Händler sollen daher auf die Rolle und die Aktivität jedes Unternehmens angepasst werden. Für die Zwecke der effektiven Marktüberwachung soll die Produktdokumentation  an einer einzigen Stelle innerhalb der Gemeinschaft, der zuständige Behörde des Mitgliedstaats, in dem sich die Datei befindet, zur Verfügung gestellt werden. Für die Zwecke der effektive Marktüberwachung zuständige Behörden sollen bestimmte Informationen über in die Vermarktung gebrachten kosmetische  Produkten erhalten. Um den Verwaltungsaufwand zu minimieren, sollen angemeldete  Informationen über elektronische Schnittstelle an zuständigen Behörden, Giftnotrufzentralen und Organisationen diese zentral für die Gemeinschaft verbunden sind, weitergeleitet werden.

Web-Portal (CPNP)für Anmeldung  von kosmetische Produkten wird KSIOK ersetzen ?

„Kosmetik-Verordnung führte  der Vereinigung der Anmeldung von Kosmetika in der Europäischen Union ein. Vom 11. Januar 2012 die für das kosmetische Mittel verantwortlichen Person
haben die Möglichkeit, die Informationen gemäß Artikel 13 der Verordnung 1223/2009 für Internet-Portal für Kosmetik-Mitteilung (CPNP) bezeichnet eingeben. CPNP Portal ist ein elektronisches System für die Anmeldung  die Kosmetika, die auf dem europäischen Markt Inverkehbringen oder zur Verfügung gestellt wird. Anderthalbjährige Zeit Funktionieren des Portals ist die Vorbereitung vor dem Datum vom 11 Juli 2013 Jahre, wenn die Nutzung des Portals ein Pflicht wird.”

Zitat von der Website: biotechnologia.pl

Art. 13 / Verordnung 1223/2009 Anmeldung:

  1. Vor  die Inverkehrbringen des Kosmetik-Produkts auf dem Markt die verantwortliche Person reicht der Kommission  die folgende Informationen elektronisch ein:
  1. Kategorie des Produkts und seinen Namen oder die Namen, die klare Identifizierung zulassen.
  2. Name der verantwortlichen Person, das Unternehmen
    und die Adresse, wo die Datei des Produkts zugänglich gemacht sind;
  3. Herkunftsland, im Falle des Imports.
  4. Mitgliedstaat, in dem das kosmetische Mittel  auf den Markt gebracht wird;
  5. Die Kontaktangaben zu einer natürlichen Person, die kontaktiert werden kann,  falls Kontakt erforderlich wird.
Art. 2 / Verordnung 1223/2009 Definitionen

Für die Zwecke dieser Verordnung gelten die folgenden Definitionen:
  1. „Kosmetische Mittel“ sind Stoffe oder Gemische, die dazu bestimmt sind, äußerlich mit den Teilen des menschlichen Körpers (Haut, Behaarungssystem, Nägel, Lippen und äußere intime Regionen) oder mit den Zähnen und den Schleimhäuten der Mundhöhle in Berührung zu kommen, und zwar zu dem ausschließlichen oder überwiegenden Zweck,  diese zu reinigen, zu parfümieren, ihr Aussehen zu verändern, sie zu schützen, sie in gutem Zustand zu halten oder den Körpergeruch zu beeinflussen;
d.  „ Hersteller“ ist  jede natürliche oder juristische Person, die den Kosmetische Mittel herstellt
        oder ein Produkt entwerfen oder herstellen lässt und dieses Produkt unter ihrem eigenen
        Namen oder Marke auf dem Mark bereitstellt.
e. „Händler“ : natürliche oder juristische Person in der Lieferkette, mit Ausnahme des Herstellers
      oder des Importeurs, die ein kosmetisches Produkt auf dem Gemeinschaftsmarkt zugänglich
      macht.
g. „Bereitstellung auf dem Markt „, jede bezahlte oder kostenlose Lieferung eines
    kosmetischen Mittels auf dem Gemeinschaftsmarkt für den Vertrieb, Verbrauch oder zur
    Verwendung, im Rahmen einer Handelstätigkeit;
h. „Inverkehrbringen“ bedeutet die Bereitstellung kosmetischen Mittels  auf dem
      Gemeinschaftsmarkt zum erste mal.
 
Art. 4 / Verordnung 1223/2009 die verantwortliche Person:

6. Händler ist die verantwortliche Person, wenn ein Kosmetikprodukt auf dem Markt unter
   seinem Namen oder Warenzeichen  bereitstellt oder  ändert ein Produkt ,auf dem Markt  
   bereits ,  in einer Weise, die einen Einfluss auf Übereinstimmung  mit den geltenden
   Anforderungen haben könnte.

  Silcare®-Florence® alle Kosmetika vermarktet  auf der Website CPNP angemeldet sind. Kosmetik sind vermarket unter Handelsname und mit dem Bild der Verpackung, in Übereinstimmung mit den Tatsachen, dass ist zu Beispiel: Base One Gel 5 g ist in CPNP wie folgt angemeldet:

 


  Wir als verantwortliche Person zeigen auf die Etikette, der vermarkte und in CPNP angemeldete Produkten, die Adresse unter welche die Dokumentation der angemeldete Kosmetik, ein so genanntes Dossier, sich befindet.

 
  Die Firma Firma Silcare® - Florence® besitzt weder keine Anmeldung noch Dokumentation für die Kosmetiken mit Handelsnamen unsere Kunden oder durch unsere Kunden vermarktet.
 

Wir empfehlen Ihnen, den gesamten Text der Verordnung 1223/2009 lesen und Bezug auf die Regulierung.

 

16. Richtige Etiketten.

RICHTIGE  ETIKETT
 
Die Stellungnahme  der Hersteller Silcare ® - Florance® bezüglich verantwortliche Person im Sinn der Verordnung 1223/2009.

  Verordnung des Europäischen Parlaments und Rat (EG) Nr. 1223/2009 vom 30. November 2009 über kosmetische Mittel  erfordert, dass das Etikett des kosmetischen Mittels enthalten u.a . Informationen über   VERANTWORTLICHE PERSON für ein kosmetisches Produkt.

Muster der richtigen Etiketten

Silcare Etikett


Das Label enthält Angaben Silcare ®
(Name, Adresse)
auftreten auf dem Etikett als Produzent (gleichzeitig Verantwortlichen Person werden)
Das Etikett kann nicht
 in irgendeiner Weise geändert werden:
*Produktname
*Farbetiketten
*Größe des Etiketts
*Grafikinhalte

Kunden Etikett ( eigene Marke)

Das Label enthält die Kundendaten, die das Produkt unter eigene Marke verkauft, mit ihrem eigenen Logo, seinen Namen- andere als die Produktname  Silcare ®
 ( gleichzeitig verantwortlichen Person werden):
*in diesem Fall zeigt das Etikett eine VERANTWORTLICHE PERSON = HÄNDLER, also Kunden
(Vollständiger Name, Adresse,
Kontaktdaten)
*  nach  Art.4 Ver. 1223/2009. Abschnitt 6.