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private label 2018 gels, creams & oils

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lubricants

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stimuli

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maintenance & cleaners

Important message! Lubricants CE class I cannot be sold after may 2020, only class IIa may be placed on the market. All the major (online) retailers like Amazon, E-bay etc. will not accept any CE lubricant that is not classed as IIa. Read on page 4 how to transition to class IIa medical device status.

EN/08-2018

cobeco.nl


Contents

2

The use of texts coming from this catalogue is for own responsibility. Subject to misprints, errors and technical modifications.


News 4

Packaging 32

Classification and related legislation / registration 42

Are you prepared?

Primary packaging

How does it work

10

Why Cobeco Benefits Formulas Delivery time Shipment Payment protocol 10 easy steps

10 11 12 13 13 13 14

Products 16 Health care Gels & Creams Body gels and body creams Intimate hygiene Massage oils and candles Massage candles Lubricants Lubricant waterbased Lubricant silicone based Special lubricants Sexual aid gels & creams Gels & creams for men Gels & creams for women Gels & creams for both Sexual health - food supplements Food supplements for men Food supplements for women Food supplements for both Liquids Sachets with wet wipes Maintenance products

16 16 17 17 19 20 20 22 23 24 24 25 25 26 26 28 28 29 30 31

32

Cosmetic products

Glass bottles & jars

32

Medical devices and CE marking

44

Plastic bottles & jars

32

Food supplements & health products

46

42

Flat packaging for internet shipment 34 Plastic tubes

34

Sachets

35

Sachets with wipes

36

Blister packs

Notification and conformity 48

36 36

Cosmetic classification prod.

49

Labeling

37

Medical device classification prod.

49

Shrink sealing

37

Food supplements

49

Carton boxes

37

Display boxes

37

Export documents

50

Leaflets

37

Gift sets

37

Production certificate and storage

50

Secondary packaging

Contents

4

Design 38 The design / what you need for the design packaging

38

Design service

39

Printed labels

40

Printed boxes

40

Printed primary packaging

41

Our extra services

41

Export documents for registration

51

Other export shipment docs.

52

Legalisation

53

Quality control

54

Quality control

54

Assortment 55 Assortment

55

Contents

3


News

Are you prepared for the regulatory changes transitioning personal lubricants to Class IIa medical devices?

Currently, personal lubricants are still being placed on the market as cosmetics and Class I medical devices. As of April 2017, the Council of Ministers and the European Parliament, have adopted a new medical device regulation which also applies to personal/ intimate lubricants. There is a transition period of three (3) years before the new law comes in full effect, i.e., from April 2017 until May 2020. This means that as of May 2020 personal lubricants identified as Class I medical devices or as cosmetic products are no longer permitted to be supplied or sold. This applies to any size and packaging of personal lubricant in the market at distributor or at retail level regardless of whether it is physically in stock or supplied through Internet sales. Before May 2020, these products must be CE-marked as Class IIa medical devices. From May 2020, personal lubricants with the intent to be used as a personal/sexual lubricant, may only be placed on the market as a Class IIa medical devices.

4


What changes precisely? 2. Conformity assessment process 1. Classification of medical devices Each risk class for a medical device is linked to a specific conformity assessment route by which the medical device is CE-marked.

News

2. Conformity assessment procedure 3. Quality system requirements for medical devices to EN ISO 13485:2016 4. Changes in regulatory requirements between Directive and Regulation medical devices

Class I medical devices are self-certified by the legal manufacturer, are notified to the relevant national competent authority and fall under the direct supervision of that national competent authority who can assess the technical documentation to ensure that the dossier meets compliance with the relevant medical device requirements.

1. Classification of medical devices Medical devices are categorised in 4 major risk classes: Class I medical devices which are devices that have no contact with the human body or have transient (short) contact with the undamaged skin1. Class IIa medical devices are products that come in direct contact with a natural body orifice (opening) or damaged skin; Class IIb and Class III are high-risk products such as implants. Personal lubricants are, however, Class IIa medical devices due to their direct contact with a body orifice (opening) or mucus membrane for a period of <24 hours continuous contact.

Medical devices in Classes IIa, IIb and III require a notified body to be involved in the conformity assessment process. The notified body assesses the technical documentation which the manufacturer has prepared and submitted for assessment and the quality system which the legal manufacturer is required to have in place. In order to ensure that personal lubricants comply with the medical device requirements as Class IIa medical devices, the products are subjected to additional and extensive testing and controls. These tests and controls ensure the personal lubricants are guaranteed a high level of safety and quality.

1) Medical devices that have continual contact with the human body <60 minutes <24 hours (Class I); of >24 hours <30 days of continual contact (Class IIa, Class IIb), or >30 days continual contact (Class IIb, Class III).

5


News

2. Conformity assessment process (continued)

3. ISO

Further, ingredients used in the formulation of the personal lubricants must meet purity levels such as defined in the monographs of the European Pharmacopeia. The legal manufacturer, additionally, is obligated to have sufficient scientific data, which is documented in the technical documentation. Class IIa medical devices also need to comply with specific labelling requirements. These obligations help ensure that personal lubricants meet the highest level of safety and quality.

Medical devices are designed and produced under the conditions set out in a good manufacturing requirements stipulated in a medical device quality system standard. The current standard EN ISO 13485:2012 is valid until March 2019, at which time it will be replaced with EN ISO 13485:2016.

Essential to the CE-marking, the notified body must conduct a conformity assessment of the technical documentation against the safety requirements stipulated in the medical device regulations and conduct an on-site audit of the manufacturerâ&#x20AC;&#x2122;s quality system. When the manufacturer passes both aspects of the conformity assessment process, the notified body issues the manufacturer with a CEcertificate of conformity. The approval stipulates that the number of the notified body is included next to or under the CE-mark on the labelling. When the number of the notified body is present with the CE-mark, it is an indication that the product and manufacturer meet regulatory requirements for the class of medical devices indicated by the product.

6

As of March 2019, manufacturers of medical devices must comply with the 2016 versions of the standard, which better guarantees the safety of processes and products.

4. Regulation Aside from the new quality system standard, a new medical device regulation is also coming into place. Currently, until May 2020, the medical device Directive 93/42/EEC is still valid. From May 2020, legal manufacturers of medical devices must comply with the Medical device Regulation 2017/745 which was published in April 2017. The Regulation tightens the medical device requirements, including giving the quality system requirements a legal impetus. Further, the new law also defines obligations for distributors and importers of medical devices including compliance with quality system and regulatory medical device requirements.


Can it be verified whether my product complies with the medical device requirements?

An approved Class IIa medical device is identified on its labelling by the CE-mark accompanied by the number of the notified body. Personal lubricants that are intended to be used as personal/intimate sexual lubricants, identified by a CE without a number are Class I medical devices. Personal lubricants without a CE-mark on the

As the medical device regulation and requirements are pan-European in nature, they apply to any and all personal lubricants on the European Union market. The national competent authorities of the member states of the Union, conduct market surveillance and enforce the requirements. Hereby, after May 2020, only personal lubricants

labelling could be cosmetic products. Personal lubricants with an intended use as personal/sexual lubricant, are not permitted to be placed on the market as cosmetic or Class I medical devices after May 2020.

which have undergone a Class IIa conformity assessment process are permitted to be placed on the market.

News

How can a Class IIa medical device be identified?

The legal manufacturer must maintain an up-to-date and certified quality system in place. When a manufacturer or a product does not meet the regulatory requirements, the national competent authorities regard this as an infringement. The authorities can require these products to be removed from the market and/or can impose necessary penalties including substantial fines. Serious infringements of the medical device requirements can, for instance, include making false claims about the product, incorrectly CE-marking the products or incorrectly classifying the products.

7


Important therefore are the following:

News

• Labelling for personal lubricants must at all times comply with the regulatory requirements for labelling as defined by the CE-marking approval granted by the notified body. • The legal manufacturer must at all times be identified clearly on the labelling. • Personal lubricants must be appropriately classified as Class IIa devices and subject to conformity assessment by a notified body. • The legal manufacturer must maintain an up-to-date and valid technical documentation for Class IIa medical devices which has been assessed by a notified body. • The legal manufacturer must maintain an up-to-date and certified quality system in place.

What can Cobeco do for you? As of the 1st quarter 2019, Cobeco will supply only CE-marked Class IIa personal lubricants to the market. Cobeco ensures that you will be able to transfer in a timely manner from a Class I medical device to Class IIa device. Cobeco has a number of solutions available for different scenarios to ensure a timely transfer is implemented that will support your activities; and will be pleased to provide you with a bespoke proposal:

1. You are an existing customer For our existing customers, we will review your labelling against the labelling approved by our notified body. We will provide you with a bespoke plan to ensure you transfer in a timely manner to the new situation.

2. You are a new customer We will prepare and provide a bespoke plan which ensures that your product or products comply with Class IIa medical device requirements.

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Should you be the owner of the product brand, then we can provide manufacturing of the product under your brand, while ensuring the product meets Class IIa medical device requirements.

4. You import or intend to import a product from outside the European Union for sales in the European Union. Products which come into the European Union from a country outside the European Union must be imported by a qualified and registered importer. Additionally, should the foreign legal manufacturer not have a seat in the Union, the foreign manufacturer must appoint an authorised representative. Further, the manufacturer of the foreign product must demonstrate complete compliance with the medical device requirements before the product can be imported. The importation of a foreign made product is associated with a significant administrative burden.

We would be pleased to support your activities and help you transition to Class IIa medical device status. We look forward to hearing from you about which of the abovementioned situations applies to you.

News

3. You have a branded product but may not be certain the supplier has the appropriate certification(s), and/or the product does not meet the appropriate requirements for Class IIa

We will provide you with a bespoke plan and solution to transition you in a timely manner to Class IIa medical device status.

Should the previously mentioned point 3 or 4 be applicable, then we kindly request you to provide a copy of your artwork, which you can send per post or by e-mail. In case the previously mentioned point 4 is applicable, then we kindly request you to provide aside from the labelling, copies of the current CE-certificates including the manufacturerâ&#x20AC;&#x2122;s Declaration of Conformity and quality system certificates. After receipt, we will provide you with a bespoke plan and solution to transition you in a timely manner to Class IIa medical device status.

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How does it work

How does it work

Why Cobeco Create your own private brand with Private Label by Cobeco Pharma Manufacturing. Cobeco Pharma has the necessary key elements for a successful private label.

Cobeco Pharma is one of the leading private label manufacturers in Europe and is well known for the innovative formulas at budget prices. This is what distinguishes Cobeco Pharma from the rest of the private label manufacturing companies and what will give you the cutting-edge advantages when doing business with Cobeco Pharma. Cobeco Pharma is situated in the Netherlands. Cobeco Pharma has low order quantities, which is unique for private labelling. If you are a startup company with a low budget, or existing company that wants to test a new product with a small bottle run, Cobeco Pharma is the private label manufacturing company to help you! We are specialized in offering small quantities at competitive

10

Why Cobeco

prices, due to our efficient production facility. Also for bigger quantities we can assist you, as we have a big capacity to supply your order in quick delivery times. Plus, our in-house research assistants and experts make sure that they keep up to date to all new developments.

Cobeco Pharma is the private label manufacturing company to help you!

We not only produce and deliver the ingredients. We are also there to advice and assist you in starting your own private label. Cobeco can assist in (creating) your concept, design, packaging, filling and even the needed registrations and marketing, or even completely take care of this. We offer custom made service to every client, at all kind of areas, from first idea until bringing your product to market.


You are able to build your brand recognition in your market, improve loyalty and repeated purchases, attain larger profits margins offering a lower retail price; a significant advertising opportunity at minimal costs. Get your company name and logo in front of your customers on a regular basis for days or months on end.

Gain exclusivity experience all the benefits of higher profits

Attention

Freedom

use your own private label as a marketing tool that will enhances your storeâ&#x20AC;&#x2122;s image

make sure you determine your own store promotions and other promotions with wider margins at your own benefit

Benefits of a private label:

Repeated purchases

Online

create more brand loyalty among your customers

quickly and easily develop a unique brand for online sales (e-commerce)

Benefits

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How does it work

A private label has many benefits. For example, it ensures an unique product with an unique appearance and will give you an opportunity to strengthen the store loyalty.

how does it work

Benefits


Formulas

How does it work

Formulas are a composition of ingredients that make a product. All formulas have a certain composition of ingredients in order to create a product with a specific function.

It is possible to buy an in-house formula and create your own private label product

In-house formulas The in-house formulas are standard formulas that are being used for the Cobeco Pharma Wholesale products. It is possible to buy an in-house formula and create your own private label product. Youâ&#x20AC;&#x2122;re able to create your own design for the label, but we can also take care of the design for you or offer you assistance.

Cobeco Pharma Contract Manufacturing Cobeco Pharma Contract Manufacturing give the opportunity to produce custom made liquids, tablets, gels, creams, powders and capsules. Each custom made formula has regulations that should be taken into account. You can provide us with your formulation which we can produce for you. The minimum order quantity for the Cobeco Pharma Contract Manufacturing depends on the packaging and product.

Bottling of packaging with your bulk We can bottle your bulk in packaging of your choice.

Bulk raw material You can order raw bulk material on selected products.

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Formulas


Shipment

Payment protocol

In-house formulas

Your finished product will be ready to be exwarehouse delivered or the finished product can be delivered by us at additional costs. The time of delivery is within Europe, 3 to 4 days. It is possible to order an urgent shipment at additional costs.

After ordering a private label, you will receive an order confirmation. In this order confirmation you can find all the details of your order, including the costs.

The estimated delivery time is dependent on the packaging. The delivery time of product with in-house formulas is between 6 to 8 weeks, after the approval of the printing proofs.

Case count packaging The delivery time of product with your own formulas is between 10 to 12 weeks, after the approval of the printing proofs. All after orders can be arranged at short notice. Urgent delivery is possible at additional costs.

The product of the order is packed per case count. A case count is the amount of products that are sealed and shipped together as one package. The amount of products that are sealed together depends on the measurements of the products. We have standard case counts for the different products we offer. It is possible to change the size of this case count at additional costs.

Drop shipment It is also possible to deliver your products as drop shipment. This means that we will deliver the products we produced for you directly at your clients. Cobeco Pharma will charge additional costs for this service.

How does it work

Delivery time

When you have received and signed this order confirmation, a prepayment is required. After we received your payment, the process planning of production will be started. When the production has been completed, we can send you a picture of your finished product, or you can visit our company and inspect the product yourself. The final payment of the remaining amount must be done at this time. After the payment is complete, your products are ready to be picked up at our company or we can ship your products to the requested address in Europe.

Delivery time / Shipment / Payment protocol

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10 Easy Steps / How to start your own private label

How does it work

Step

1

Choose a product.

Step

2

Choose the packaging.

Step

3

Send us your request and preferred quantity.

Step

We will send a quotation, an order confirmation and an estimated delivery time.

4

Step

5

14

Sign the confirmation and please make the pre-payment.

10 Easy Steps / How to start your own private label


When we have received the pre-payment, we will send you the template for the design. The template and the legal text are dependent on your requests.

Step

The design has to be sent back to us. We will check the design and after our approval, you will receive the first digital sample of your label. After signing, the actual product will be produced.

6 7

How does it work

Step

Step

8

We will print the packaging and start the production.

Step

Dependent on the payment, your product will be sent within the specified time.

9

Step

10

Your product can be shipped.

10 Easy Steps / How to start your own private label

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Products

Products Cobeco Pharma has a wide variety of products that are available for private label. This will give you the opportunity to bring your perfect product lines within your private label brand to market. Check out our different formulas for different purposes. Or make your private label request and we will look for the most appropriate formula to offer you.

Health care - Gels and Creams Cobeco can offer a wide assortment of creams and gels. The creams and gels come in a variety of products for the body and face.

Body gels and body creams Cellulite gel The natural ingredients of this gel moisturize and hydrate the skin of the buttocks and thighs and help against cellulite and other imperfections. Containing ingredients like Hedera Helix, Juniperus communis, Arnica Montana. Slimming gel The natural ingredients of this gel firm the skin and have a slimming effect. The gel moisturizes and hydrates the skin. Bodyshaping gel / creams Our body shaping formulaâ&#x20AC;&#x2122;s give aid to firming skin of the busts and helping against imperfections. Containing ingredients like Calendula, Ylang Ylang, Fucus Vesiculosus.

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Health care - Gels and Creams

Skin lighten cream People can have imperfections on the skin in tone colours. This can have an effect on the mental well being and can make people get insecure. For this we have a skin lighten formula. It contains of active ingredient that lighten the skin and help to prevent and reduce pigmentation, age spots and freckles. After depilation gel Especially after depilation the most intimate places may experience irritation. The gel prevents the occurrence of irritation. This unique gel nourishes, nurtures and protects the skin to ensure a relaxed and refreshed feeling. With Mentha Piperita oil and Allantoin.


Massage oils and candles

Soap free intimate wash gel The intimate wash gel is a soap free gel and especially designed for personal hygiene. It refreshes the intimate area in a quick and easy way and can be applied under the shower or in bath. It is the perfect complement to the daily intimate hygiene.

Cobeco Pharma offers the opportunity to create a brand of massage oils. The massage oils are available in liquids and we also supply massage candles.

Products

Intimate hygiene

Intimate hygiene wipes The intimate wipes for men or women refresh the intimate area in a quick and easy way. The wipes clean intensively without irritation. The cleaning wipe is soap free and gentle to the skin. The wipes are easy to take with you, for a fresh and hygienic feeling at any time. Intimate cleaner liquid for men The intimate cleaner for men is especially designed for personal hygiene. It refreshes the intimate area of men in a quick and easy way. For a fresh and hygienic feeling at any given time. The cleaner cleans quickly and easy and is the perfect complement to the daily intimate hygiene of the man.

Massage oils Cobeco Pharma offers the opportunity to create a brand of massage oils. The massage oils are available in different scented oils. A massage can relieve stress, it can be stimulating and it can give a boost to the libido. The massage oils all nurture and moisturise the skin. Health care - Gels and Creams

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Products

The oils are smooth and soft for the skin. They will nurture and moisturise your skin at the same time. The oils are non-greasy and all have different special features. The different oils we offer:

Neutral oil A neutral, scentless, standard massage oil. This oil can be used in almost any type of massage oil with any purposes. None scented, none flavoured or none coloured. Joyfull oil Refreshing, sensual massage oil. Nongreasy, non-sticky with moisturising features that can be used as a nurturing skin care product after showers. Herbal oil The perfect sensual massage oil with an herbal character.

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Health care - Gels and Creams

vanilla

Exclusive oil Massage oil that makes every massage a unique erotic experience. Balans oil Experience a fresh, sensual massage with Balans oil. Warming oil The warming massage oil will warm up when massaged onto the skin. Use all your senses while things heat up.

citrus

agarwood

Relaxing Vanilla oil This relaxing massage oil has a sweet vanilla scent. Treat your partner to the ultimate massage. Citrus oil Give your partner a fresh and sensual massage with citrus scented massage oil. Argan oil Special Eastern oil, also known as Moroccan oil or liquid gold. Argan oil has moisturising and nurturing features and can be used in many types massage oils for many purposes.


Massage candles The massage candles by Cobeco Pharma are massage candles that are available in three different scents. Perfect massage oil The Cobeco Massage candles make the perfect massage oil for sensual massages. The candles have a perfect melting point, melting at a temperature of 35 degrees and can be used directly onto the skin. The massage candles are made of high quality cosmetic oils and Shea butter. The silky features nurtures and moisturises the skin. The Cobeco Pharma massage candles are available in one colour, white.

There are three sensational scents to choose from:

Appletini Ripe sweet sparkling apple scent with hints of peach, pear and strawberry.

Products

Tin jar The tin jar is available in one shape. It is possible to place stickers on the sides, top and bottom of the tin jar with your desired design. The carton box can be an option for the tin jars but is not a requirement.

silky features nurtures and moisturises the skin

Spring flower Fresh, floral and fruity.

Wild Bamboo and Orchids Fresh woody scent with hints of orchids.

Health care - Gels and Creams

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Lubricants

Products

Lubricants are used during sexual intercourse. The use of lubricants during sexual intercourse can enhance sexual pleasure and make sex more comfortable. Cobeco Pharma offers different types of lubricants.

Water based Water based lubricants are based on water and have many advantages. A water-based lubricant is compatible with latex and is condom safe. Also, water based lubricants can be used with virtually any sex toy. Lubricants that are water based are smooth and non-sticky. Our water-based lubricants are available in many different types of lubricants such as flavoured lubricants, anal lubricants and warming or cooling lubricants:

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Lubricants


// Anal lubricants The anal water based lubricants have a thicker structure to provide smooth penetration. This will create more pleasure during anal sex.

// Flavoured lubricants Flavoured lubricants make sex even more enjoyable. The flavour options can be as exotic as Guarana or Passion fruit. We offer different flavours like: Cherry, Chocolate, Forest Fruit, Passion fruit, Pina colada, Strawberry, Vanilla and also scents like: Aloe vera, Guarana and Cannabis Oil.

// Warming lubricant The warming lubricant will warm up after coming in contact with the skin. Use all your senses while things heat up. The warming lubricant is designed for more sexual pleasure and comfort.

// pH Neutral lubricants The pH Neutral lubricants are lubricants that have a neutral pH value. pH Neutral lubricant is a water based lubricant that is suitable for sexual intercourse.

// Cooling lubricant The cooling lubricant will cool you down when it gets massaged on the skin. Use all your senses and enjoy the cooling properties. The cooling lubricant is designed for more sexual pleasure and comfort.

// White lubricants White lubricants are lubricants that have a white colour. The lubricant is especially developed to make anal sex a pleasant and smooth experience and is soft for the skin.

// Relax lubricant The relax lubricant has relaxing properties that make the skin less sensitive; this makes the lubricant especially suitable for anal intercourse.

// 100% natural lubricant 100% Natural & Vegan Lubricant Water Based is free of Parabens, synthetic fragrances, colourings and aroma’s. It is pHoptimised and respects the healthy vaginal bacteria.

Products

// Neutral lubricants Neutral lubricants make sex even more enjoyable. The advantage of natural feel is that it has no odour and no colour. The lubricant is soft and pleasant for the skin.

The 100% Natural Lube ensures all natural and long lasting lubrication due to its hydrating and moisturising effect. It is condom-safe and doesn’t dry out over time during use.

our natural lubricant is suitable for vegans

Lubricants

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Silicone based

Products

A silicone based lubricant is a lubricant that is based on silicone. Silicone based lubricants contain no water and will not be easily absorbed by the skin. This is why a silicone based lubricant will last longer than a water based lubricant. Silicone based lubricants are not always suitable for sex toys. The silicone can damage the material of which the sex toy is made of.

// Silicone Scented The silicone lubricants comes neutral, but we also offer different scents like Jasmin and passion fruit.

jasmin

22

Lubricants

// Silicone Cooling The silicone cooling lubricant generates a cooling and tingling sensation upon contact with the skin which peaks arousal. Blowing or rubbing the lubricant into the skin activates the cooling elements to achieve the desired effect.

// Silicone Warming The silicone warming lubricant has a gliding texture and will warm up after coming in contact with the skin. The pleasant warming effect in combination with the long lasting properties of a silicone lubricant makes sure things stay heated up or a very long time.


The special lubricants are an addition to our assortment of basic water based or silicone based lubricants. Extra thick lubricant The extra thick lubricant is especially developed for a smooth experience of anal sex. The extra thick lubricant has a much thicker structure than any other lubricant and ideal for anal sex. The extra thick lubricant is long lasting and is easy to rinse off with water. The extra thick lubricant is odourless, tasteless and is colourless Butter lubricant The butter lubricant has the structure, thickness and smoothness as you may expect from a real butter. Butter lubricant lubricates easy to use and will give long lasting lubrication where it is needed. The butter lubricant is odourless, tasteless and is colourless

Cream lubricant This is a silicone based cream which moisturizes and smoothest the skin to enhance his sensual experience. It gives more comfort during heavier sensual play activities, which makes this experience more intense. It does not get absorbed by the skin, which creates a long lasting pleasurable gliding feeling.

2 in 1 lubricant + massage gel (hybrid)

Products

Special lubricants

Powder lubricant The powder lubricant is a powder that has to be mixed with water to obtain the correct thickness. When combined with water it becomes a perfect lubricant. You can control the thickness by adding or leaving out water in the mix. The powder lubricant is odourless, tasteless and has a white colour.

The 2 in 1 lubricant + massage gel (hybrid) is a special water based gel with the features of a silicone based gel. Easy to rinse off with water. Ideal for massages, body-to-body massages and sexual intercourse.

1) Place the desired amount in a bowl or cup. 2) Add water. 3) Stir until smooth. 1

2

3

4

4) Enjoy your lubricant. Add more water for less thickness.

Lubricants

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Gels and creams, liquids for men

Sexual aid gels & creams

Products

Cobeco Pharma offers a wide assortment of creams and gels. The creams and gels come in a variety of products for the skin, body shaping, sexual support and more.

- Delay aid for men A premature ejaculation is uncomfortable for many men and their partners. These men come faster than they would like, which results in less time for the sexual pleasure. The exclusive Delay Gel and Delay Cream, Delay Liquid Spray temporarily numbs the head of the penis, causing it to become less sensitive and helps to prevent a premature ejaculation. These unique products give more control and provide long lasting maximal pleasure during sexual intercourse. - Erection support for men The erection support cream and lotion are products that can help with getting an erection. The formula is based on natural plant extracts, that stimulates the blood circulation of the male genitals, which makes getting an erection possible. This product contains among others ginkgo biloba.

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Sexual aid - gels & creams

- Arousal aid for men Viagel for Men is a nourishing and stimulating gel for the intimate areas of the men. The gel increases desire and lust. The natural effect of these high quality ingredients in this unique gel create a more intense experience during intimate moments. Viagel for Men warms the skin of the penis and gives it a little tickle and tingle, in a pleasant way. - Body shaving After Shave Gel for Men ensures a smooth, soft and groomed skin after shaving. Use this unique gel after each shave. It soothes and nourishes the skin, while it prevents irritation and ingrown hairs.


- Arousal aid Intimate cream and intimate gel nourish and stimulate the intimate female area and give a tingling, warm and sensual feeling. For more excitement, arousal and joy. The cream formula based on natural ingredients and rich oils stimulates the womanâ&#x20AC;&#x2122;s intimate areas. The skin will become more sensitive when touched and youâ&#x20AC;&#x2122;ll experience an increasing sexual desire. The tingling stimulation of the clitoris will thereby intensify the pleasure. The high quality ingredients in this gel formula, create a more intense experience during sexual intercourse. The gel warms the sensitive skin of the clitoris and gives it a tingle in a pleasant way. - Tighten aid With age or after having children, women can experience a widening of the vagina. Tightening gel is an unique gel that nourishes the delicate skin of the vagina, thanks to the various high quality ingredients like flower and

Gels and creams, liquids for both

plant extracts, including allantoin, calendula, aloe vera, hamamelis Virginiana leaf extract and chamomilla recutita flower extract. The gel supports the skin of the vagina, has a restorative effect and can make it feel firmer. This will help to experience more intense sexual intercourse.

- Flavoured gels We offer nourishing and pleasure enhancing oral gels to enhance intimate oral pleasure. The sensual taste of these gels will surely seduce you. Available in different fruity flavours: strawberry, tropical an vanilla.

- Body shaping Our breast shaping formulaâ&#x20AC;&#x2122;s cream and gel stimulates firming the skin of the breasts and it will help to increase imperfections. Thanks to natural ingredients like calendula, ylang ylang and fucus vesiculosus.

vanilla pods

- After depilation Get prepared for a sexy night out. Depilation, waxing or shaving the most intimate places may cause irritation. After Depilation Gel - Bikini prevents this irritations. This unique gel nourishes, nurtures and protects the skin to ensure a relaxed and refreshed feelin. Contains with mentha piperita oil and allantoin.

Products

Gels and creams, liquids for women

- Skin lighten anal spot Some people have imperfections of the tone of their skin. Lack of a flawless skin can have a serious effect on the mental well being and can make people get insecure. Our skin lighten formula is the perfect solution for this problem. It contains active ingredients that lighten the skin and help to prevent and reduce pigmentation, age spots and freckles. It is also suitable for the anal spot area.

Sexual aid - gels & creams

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Sexual health Food supplements

Products

Cobeco Pharma offers the opportunity to create a private label brand of food supplements in sexual wellness categories. The body needs vitamins and minerals to function healthy. Being healthy also has its effect on a healthy sexual wellbeing, for the mind and for the sexual organs to function properly. Due to circumstances or because of getting older, sometimes supplements can be a helpful addition to the daily diet.

The food supplement category consist of tablets and capsules, drops and drinks. We can offer you a wide variety of tablets and capsules with different features and colours for your perfect brand.

Customize possibilities: •  Colour: the basic capsules are white or transparent. For additional amount you are able to choose any colour you like. •  Vega: the capsules are also available in capsules suitable for vegetarians. The vegetarian capsules are only available in a transparent colour. •  Printing: It is possible to customize your tablets by having your name printed on the tablets. Cobeco Pharma will charge additional costs for this service. The minimum order will be one million tablets. We offer these food supplements in a wide variety of categories.

many different colours available

26

Sexual health - Food supplements

Food supplements for men - Masculine We offer several herbal formulas for the sexual health and masculinity of men. These formulas consists of well known ingredients, such as tribulus terrestris, Siberian Ginseng, L-argine and saw palmetto.


Higher levels of testosterone can the increase lean muscle mass, strength, energy, libido and has good influence on the mood. Testosterone is also essential for the maintenance of bone density, fat distribution, red blood cell production and sperm production.

Being healthy has its effect on a healthy sexual wellbeing, for the mind and for the sexual organs to function properly.

- Erection aid Many men have experienced problems with getting an erection. Sometimes the problems are caused by medical problems, but in many cases itâ&#x20AC;&#x2122;s because of other circumstances or diet. If itâ&#x20AC;&#x2122;s not medical, than supplements can help out. The main cause of male impotence is poor circulation and impaired blood flow through the penis. Research also learns that certain vitamins and supplements can also contribute to get an erection. Like herbs such as ginkgo biloba, ginseng and maca are known for their beneficial support. As erections are the result of increased blood flow to the penis, vitamins that improve blood circulation can be helpful. As well as getting smooth muscle relaxation. Ginkgo biloba works best when combined with Ginseng. It is said to be effective at improving the blood flow and stimulate erections. Scientific studies of Ginseng are showing positive effects on erections,

desire and overall sexual satisfaction. Improvements in libido and performance are also noticed. - Spermatogenesis and virility Proper nutrition is essential for health. Deficiency of one or more essential nutrients will have a negative impact on the bodyâ&#x20AC;&#x2122;s function. A number of vitamins and minerals, such as vitamin A , C, folate, B6 and zinc, are particularly important for spermatogenesis and male virility, which comprises vigor and reproductive health. In addition, our herbal extracts formulations assist in increasing and maintain virility.

Products

Tribulus terrestris supplements stimulates the production of luteinizing hormones. This hormone encourages cells in the testes to produce testosterone, which is a powerful anabolic hormone that causes a wide range of effects in men.

ginseng root

Sexual health - Food supplements

27


Products

Food supplements for women

Food supplements for both

We offer several herbal formulas for the sexual health for women. These formulas consists of well known ingredients, such as tribulus terrestris, Siberian Ginseng, L-argine and saw palmetto.

Stamina Both men and women could sometimes use some support to stimulate their sexual desire and sex drive. We offer different herbal supplement formulas, containing among others damiana and maca, herbs well known for sexual support.

Quoted:

‘Damiana functions as a sex stimulant that not only boosts libido, but also enhances sexual pleasure. Damiana’s ancient reputation as an aphrodisiac is reflected in one of its Latin names--Turnera aphrodisiaca. The results of a 2009 ethnopharmacological study by Mexico’s National Institute of Psychiatry support the folk use of damiana as an aphrodisiac. They also point to the herb’s possible therapeutic properties in the treatment of sexual dysfunction. This prosexual effect is attributed to the mechanism of action of compounds called flavonoids, which are found in damiana leaf. According to Wellness International Network, damiana also helps revive sex drive in perimenopausal and menopausal women by replenishing depleted testosterone. Stimulating testosterone, the hormone behind both men and women’s sex drives, helps to restore sexual desire and performance.‘

damiana

28

Sexual health - Food supplements


We offer our health supplements in liquid formulations as well. These are easy to take and have the same sexual wellness beneficial properties.

- Spermatogenesis and genital health Proper nutrition is essential for health and a deficiency of one or more nutrients will have a negative impact on the body’s function. This can cause negative effects on the sperm production. We offer supplements, based on herbs as salix alba and zingiber officinale, that can be beneficial for men. Salix alba extract helps to maintain genital health. Zingiber officinale contains manganese, which is essential for neurological health. It is necessary for realeasing the sexual hormone testosterone.

liquid food supplement

Manganese is also important for men’s sex drive and sperm production. Ginger is successful in neutralizing the generally salty/ bitter taste usually attributed to the male ejaculate.

- Stamina and sexual energy Both men and women could sometimes use some support with their sexual desire and sex drive. We offer formula’s in liquid form, which are easy to take.

Products

Liquids

muira puama

The formula’s provide in more energy, which is nessecary for improvement of sexual desire and sex drive. These formula’s are based on, amongst others, vitamins, guarana, muira puima and arginine.

Proper nutrition is essential for health and a deficiency of one or more nutrients will have a negative impact on the body’s function. Sexual health - Food supplements

29


Sachets with wet wipes

Products

Cobeco Pharma’s Private Label sachets with wet wipes are efficient and convenient. The compact wipes contain a perfect amount of cleaning product or delay gel to serve your needs. The amount of bulk product on every wipe varies between 3ml and 4ml per wipe. There are different kinds of wipes to choose from:

✔ toy cleaner wipes ✔ intimate hygiene wipes ✔ delay gel wipes

These are just samples of a variety where you can choose from. Please send your request for different amounts or more information.

Toy cleaner wipes Toy Cleaner wipes are discreet and hygienic wipes with an effective cleaner without alcohol and are especially suitable for cleaning erotic toys. By cleaning toys regularly you maintain the quality of the product. Our toy cleaner does not affect latex, rubber or silicone toys. The toy cleaner wipes are disposable.

30

Sachets with wet wipes

Intimate wipes Intimate wipes are especially designed for personal hygiene. The intimate wipes are neutral for the skin and can be used regularly. The intimate wipes can be used anywhere, anytime. The Intimate wipes are disposable.

Delay wipes Delay wipes help to delay the ejaculation. Apply the delay wipes on the penis and massage the liquid that is on the wipe into the skin. The liquid will delay the ejaculation but will not stun the skin. Delay wipes are disposable.


Maintenance products

Toy cleaner

Talcum powder

Leather and latex spray

The toy cleaner is an effective cleaner without alcohol and is suitable for cleaning your erotic toys. When you clean your toys regularly you are maintaining the quality of the product and you are making sure the toys are hygienic and safe to use. The toy cleaner does not affect latex, rubber or silicone toys.

To ensure the quality of your favourite leather clothes, it is important to regularly take care of them with specific products. Cobeco Pharma talcum powder is especially created to maintain your favourite leather or latex clothes and will make it easier to put on and off your leather outfits.

To ensure the quality of your favourite leather clothes it is very important to maintain them regularly with special products, that not only preserve the leather but also make it shine, smooth and flexible. Our leather and latex spray will keep the material in perfect condition.

The talcum powder is available in a special powder dispenser. The bottle has a powder spray cap and is available in one size.

The leather and latex spray is available in different bottle sizes and has a spray cap. The product itself is milky white.

With a special pump closure the toy cleaner can be made a foaming cleaner.

Also available: sachet with wipes for toy cleaning

Products

To maintain the quality of your special toys, leather or latex clothing or objects you need cleaning products that are specially created for these materials. Cobeco Pharma offers a variety of products that are perfect for these purposes.

Cobeco Pharma offers a variety of products that maintain the quality of your special toys, leather or latex clothing.

Maintenance products

31


Packaging

Packaging

Private Label by Cobeco Pharma has many packaging options for you to choose from. This way you can create your perfect private label. If you may not have found your preferred packaging here, please send your request to our sales department.

Primary packaging The primary packaging is the packaging that comes into direct contact with the ingredient. We offer a large assortment with lots of choice; glass, plastic, special flat packages, suitable for web order shipping, sachets and blister packs. Glass bottles & jars Glass packaging is suitable for liquids and tablets and for gels and creams. The glass bottles and glass jars have the advantages of optimal protection of the product. It also gives your product a luxurious look. Glass containers are fragile and are less suited for web order shipping. We offer special plastic flat pack containers that are more suitable for web order shipping.

32

Primary packaging

- Glass bottles (liquids and tablets) Glass bottles are suitable for liquids and tablets and available in 15ml, 30ml or 100ml. The standard colour of the glass bottles is amber. A 15ml glass bottle can be ordered in blue or green. The glass jars have a screw cap and can be ordered with or without nozzle cap.


- Plastic bottles (tabs / powder) Plastic jars are suitable for tablets, capsules and caplets or powders. Jars are provided with a protection seal for optimal protection of your product. Plastic jars are available in 75cc, 100cc, 150cc or 200cc and in white, black or grey/silver. Different packages, like 1250cc and 1500cc, are also available on special request.

- Plastic bottles (gels / creams) Plastic bottles for liquids, gels and creams are available in sizes from 15ml up to 1000ml.

Packaging

Plastic bottles & jars Jars can be used for creams or gels and tablets, capsules or caplets. The jar makes sure the product is airtight, to make sure quality remains.

- Plastic jars (gels / creams) Plastic jars for gels and creams are available in size 250ml. These jars have a wide opening and are available in black or grey/silver.

Primary packaging

33


Plastic tubes

We have special plastic flat packages that can be easily send by post. We have special packages for tablets and capsules or for gels and creams. These fit directly through the mailbox and are especially suitable for orders by internet.

Tubes are ideal for oils, creams, and gels. Tubes are very hygienic and easy to close. The tubes are available in 30ml, 50ml or 100ml, in white, clear, black or grey. Our tubes can be labelled, but also sleeved or directly printed or orientated tubes (depending on the amount of the order). Options for other colours also depend on the order amount.

Packaging

Flat packages for internet shipment

- Internet flat pack (tablets) The flat packs are available in 175cc or 275cc and hold 20 up to 120 tabs/caps. The flat packs are available in the colour white.

MAILBOX SUITABLE PACKAGE

34

Primary packaging

- Flat oval plastic bottles (gels / creams) Bottles are plastic bottles that are available in different colours and sizes. Perfect for liquids and gels. The plastic bottles are available in 30ml, 50ml, 80ml, 100ml, 150ml, 250ml, 500ml or 1000ml. All other sizes of plastic packaging are available on request. Closures are sprayers, flip caps, pumps, vacuum pumps or trigger sprayers.


Sachets Sachets are thin aluminium foil bags that can contain oils, creams and gels. They can be used for retail purposes or as a promotional item. Sachets are being used as a cost-effective way to promote products by providing a free sample to customers. Sachets are being sold for single use only and are disposable. The amount of content of the sachets depends on the product type. Oil sachets could contain 1 ml more than gels because of their density.

size

content oils

content creams/gels

cap oil

cap creams/gels

50x80

3 ml

5 ml

1 mm white

4 mm white/black

50x100

6 ml

8 ml

1 mm white

4 mm white/black

50x120

8 ml

10 ml

1 mm white

4 mm white/black

60x80

3 ml

4 ml

1 mm white

4 mm white/black

60x100

4-5 ml

5-6 ml

1 mm white

4 mm white/black

60x120

12 ml

15 ml

1 mm white

4 mm white/black

65x120

12 ml

15 ml

1 mm white

4 mm white/black

72x120

13 ml

18 ml

1 mm white

4 mm white/black

Packaging

Sachets rectangular

Standup sachet size

content oils

content creams/gels

cap oil

cap creams/gels

60x100

10 ml

12 ml

1 mm white

4 mm white/black

60x120

18 ml

20 ml

1 mm white

4 mm white/black

72x125

26 ml

30 ml

1 mm white

4 mm white/black

72x140

42 ml

50 ml

1 mm white

4 mm white/black

72x150

50 ml

60 ml

1 mm white

4 mm white/black

Sachets square Monodose stick

size

content oils

content creams/gels

cap oil

cap creams/gels

60x60

2 ml

3 ml

no

no

size

content oils

content creams/gels

cap oil

cap creams/gels

72x70

4 ml

5 ml

1 mm white

4 mm white/black

25x80

5 ml

5 ml

no

no

80x80

6 ml

10 ml

1 mm white

4 mm white/black

25x100

8 ml

8 ml

no

no

90x90

8 ml

12 ml

1 mm white

4 mm white/black

25x120

10 ml

10 ml

no

no

100x100

15 ml

20 ml

1 mm white

4 mm white/black

25x130

12 ml

12 ml

no

no

Primary packaging

35


Packaging

Sachets with wipes

Blister packs

Our sachets are also available with wet wipes. Wet wipes are non-woven and can be combined with all our liquid products.

Blister packs are pre-formed plastic packages and are used for tablets, capsules or caplets. There are standard measurements, often shaped for 2 to 10 tablets, capsules of caplets to fit in. The blister strips can be printed, depending on the amount of the order.

For examples, see products: ‘sachets with wet wipes’ (pag 30).

Secondary packaging The secondary packaging is the packaging that is secondary to the product. It doesn’t come into direct contact with the ingredient. We offer secondary packaging options such as labelling, shrink sealing, carton boxes, display boxes, leaflets and gift sets.

Carton boxes can give your product a more luxurious appearance The carton boxes, display boxes, leaflets and gift sets are all additional options to complete the look of your private label. Carton boxes can give your product a more luxurious appearance. You can print the carton boxes in full colour or optional in metallic colours. We offer many options for the finishing of the carton boxes.

36

Primary packaging / Secondary packaging


Shrink sealing At additional costs we can shrink seal your products. With shrink sealing we seal the whole product.

Carton boxes Carton boxes are optional. You can choose to offer the products in boxes with the same logo and text as the labels on the actual products. Or you can choose for a box with cutaway sides, that will show the product inside the box. Cobeco Pharma will provide you with the technical information and templates after order confirmation.

Display boxes Display boxes can be used to showcase your products all together and with your logo. Display boxes are ideal to use on a shop counter to show your brand to your customers.

Packaging

Labeling Labelling your private label products is required, because the label informs the customers about the ingredients and instructions.

Leaflets Leaflets is the perfect solution if you would like to add some more information, and/ or in different languages. Leaflets can also be used to pay attention to your other products. Gift sets We offer the possibility to design and create personal gift sets. Itâ&#x20AC;&#x2122;s a nice way to show your customers more than one product of your exclusive product line at once. You have the opportunity to divide the gift boxes to your own wishes.

you can design and create your personal gift set Secondary packaging

37


Design Design

Design, printing process, other services; the design will determine the look and feel of the brand.

What you need for the design packaging 1) Template The packaging needs to be designed on templates. These templates show the outline and die cut of the packaging. The template will be an Adobe Illustrator file and/or PDF, which can be used to create an own design based upon type font, colour and imagery. Please note that colours may vary between monitor and when label is actually printed. More detailed instructions will be included with the templates. 2) Legal text Every product needs legal text on the packaging. This legal text informs the customers about the ingredients, how they support the function of the product and how the product is correctly used. This information is a requirement and cannot be altered. There is no fixed position on the packaging where this legal text should be placed. How much space it will take depends on how many languages you want on the product. There are regulations concerning the minimum height of the used type fonts for the legal text.

38

What you need for the design packaging

box template

After order confirmation, Cobeco Pharma will deliver the legal text together with the blank templates. We provide the information to the best of our knowledge; the final labelling will be under responsibility of the client. If you need advice or a helping hand with creating your brandâ&#x20AC;&#x2122;s label and/or look our specialized team of DTP professionals and graphic designers are more than happy to help you. Cobeco Pharma will charge additional costs for this service.


There are certain important notes concerning the positioning and use of barcodes. Please make sure you always use 100% black for barcodes. When scaling always scale linear (scale heights and width with the same percentage). The barcode itself has a minimal width of 25mm. The lines (the shortest ones) must be minimal 5mm high. There must also be 3mm free of print around the barcode and there must be white underneath the barcode.

4) Colours A printing process can make use of full colours (CMYK), or of PMS, depending on the process of the packaging that needs to be printed. Mostly the process is in full colour. The printing process full colours use Cyan, Magenta, Yellow and Black (CMYK).

cyan magenta yellow black The printing processes of sachets and of printed bottles make use of PMS colours. These are colours that are not build from CMYK but are printed as separate colours. These colours come from a Pantone Matching System colour library and are called PMS colours.

Design service Our specialized DTP team can help you with the last adjustments of the packaging. If you need help with placing the barcode or label on the packaging or you need advice about the measurements of the final document, they are at your service. Cobeco Pharma will charge additional costs for this service.

Design

3) Barcode There are two options for the barcode. Cobeco Pharma can generate a barcode for you or you can supply us with your own barcode.

No inspiration? The specialized graphic design team will work with you to create your perfect brand label. Cobeco Pharma will charge additional costs for this service.

5) Intellectual property Cobeco Pharma requires the client to warrant that the client owns, or has valid, licences to the intellectual property (as brand names, used logos etc). The client is responsible and liable for the designed logos and used brand names. Design service

39


Design

Printed labels Make sure that text is still readable (no less than 3 points) and that itâ&#x20AC;&#x2122;s not too close to the edge (minimum of 3 mm). The barcode should be preferably vertical, as this way it is easier to scan.

next bottle. This is possible in two different ways, through a contrasting label colour or by Eyemark. The sensor of the labelling machine reads out the top 5 mm over the whole width of the label.

Our design department will give advice and guidelines to have an optimal result. We will print the labelling according instructions and responsibility of the client.

The eye mark is a contrasting coloured rectangle of at least 3 mm wide and 5 mm high. This mark has to be placed at the top of the label on no specific place.

The material and colours The materials we mainly use for our labels are polyethylene and polypropylene. You can also opt for metallic base material or non-label look. This is on request and for additional costs. You can use full colour for the labelling.

The eye mark is present on the template as a separate layer. Please turn this layer on and place the mark on your design. Create your artwork on the â&#x20AC;&#x2DC;ARTWORKâ&#x20AC;&#x2122; layer.

Eye mark The labelling machine will attach the label to the bottle in a rotating manner. The machine however needs an indication when the rotation has been completed, in order to release the labelled bottle and start the

40

Printed boxes

Printed labels / Printed boxes

eye mark

For the outside packaging (boxes) we use 280 grams 1-side solid bleached sulphate cardboard. Our print house has state-of-the-art Heidelberg and KBA printing machines with respectively 5 ink units + lacquer and 4 ink units + inline cold-foil (standard used foil: silver). Printing colours The printing process uses full colours cyan, magenta, yellow and black (CMYK). Optional cold foil can be chosen. Sometimes we have request for PMS colours. These are colours that are not built from CMYK but are printed as separate colours. These colours come from a Pantone Matching System colour library and are called PMS colours. PMS colours are possible and depend on the total order quantity of the products with printed boxes. In our quotation we will inform you about the costs and needed minimum quantities. Finishing You can choose between two ways of finishing, glossy or matt finishing. Glossy works like a glossy film. It will be printed on the colours/paper and form a layer. The finishing of glossy can be used all over, to cover the entire artwork. Or it can cover certain areas like figures, lines or words. Matt finishing is all over the artwork.


Printed bottles Besides printing labels we can also print directly on the bottles. This is done using silkscreen. For silkscreen use preferable colours at 100% density and make sure the text is not too small. You can use PMS colours.

Our design department will give advice to have an optimal result. Printed tubes Tubes can also be printed. We make use of offset PMS printing; so all colours have to be in PMS. Make sure to provide us the artwork in PMS. Our design department is happy to help and advice you at any time, to guarantee best results. After the client approves the design, we will print the label (according to instructions and by responsibility of our clients).

Our extra services Printed sachets Sachets can only be printed offset. So all colours have to be in PMS. Make sure to provide us the artwork in PMS. Our design department is happy to help and advice you at any time, to guarantee best results. After the design is approved by the client, we will print the label (according to instructions and by responsibility of our clients).

Trademark registration It is possible to register your product name as a trademark. If you would like to have some references of trademark registration companies we would recommend, please contact us, .

Design

Printed primary packaging

Marketing All marketing texts are in your control. We offer a service that can take care of the texts for you, at additional costs. There are legal requirements that have to be taken into account. Cobeco Pharma offers a photo service that provides you of professional pictures of your finished product for marketing purposes, at additional costs. Translation of texts We will send you the legal text in languages English, Dutch, German and French. When you prefer more languages, we can offer a translate service. You can have as many languages on the packaging as long as there is enough space for it. The languages that are required depend on the countries you would wish to sell your products.

Printed primary packaging / Our extra services

41


Classification and related legislation / registration

Classification and related legislation / registration Classification and notification of the product. To bring your product to market you will have to meet several requirements and comply with certain rules. Certain products need to be notified before bringing them to market. The registration procedure depends on the kind of product. If necessary, Cobeco Pharma can assist you with the notification procedures.

Cosmetic products Definition of a cosmetic product The European Union Cosmetics Directive defines a cosmetic as:

42

Cosmetic products

any substance or preparation intended to be placed in contact with the various 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 exclusively or mainly to cleaning them, perfuming them, changing their appearance and/ or correcting body odours and/or protecting them or keeping them in good condition.


Notification of a cosmetic product When your private label product is a cosmetic product, it has to be registered at the Cosmetic Products Notification Portal (CPNP). This is a European notification system created for the ‘implementation of regulation (EC) N° 1223/2009 of the European Parliament and of the council on cosmetic products’. If preferred, Cobeco Pharma can arrange this notification for you and you will receive the Notification in CPNP.

Responsible person For each cosmetic product that is being sold on the European market, a responsible person or company has to be assigned. This responsible person guarantees the compliance of the safety, documentation of product information, the notification and the consumer information.

1

Classification and related legislation / registration

The European Union requires that cosmetic products placed on the EU market be safe; that is, they “must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. Examples of cosmetic products that Cobeco offer under private label, are creams, lotions, gels and oils. If a product is not defined as cosmetic, but it does come into contact with parts of the human body, it becomes the product group ‘product safety’. In that case, the legislation of safety rules for cosmetics, that are needed to bring the product to market, are also followed.

Cobeco Pharma offers you three possibilities to arrange the ‘responsible person’ of the cosmetic product at additional costs:

2

3

Cobeco Pharma as responsible person of the product

The customer as responsible person of the product (1)

The customer as responsible person of the product (2)

Cobeco Pharma will arrange the product information file and will complete the CPNP registration for the cosmetic product under the name of Cobeco Pharma. This means that Cobeco Pharma is responsible for the details of the CPNP registration being correct and authorities can contact Cobeco Pharma in case they have questions or need further information.

When requested, Cobeco Pharma will arrange the product information file and provide it to the customer. The customer is responsible for the CPNP registration. The customer is responsible for the details of the CPNP registration being correct and authorities will contact the customer in case they have questions or need further information.

Cobeco Pharma will arrange the product information file and will complete the CPNP registration on behalf of the customer. This means that the product will be registered in the CPNP portal under the name of the customer himself. The customer is responsible for the details of the CPNP registration being correct and authorities will contact the customer or Cobeco in case they have questions or need further information. Cosmetic products

43


Classification and related legislation / registration

Medical devices and CE marking Definition of a medical device

Examples of medical devices that Cobeco

Medical Device - According ISO 13485

offers as a private label are lubricants with intended use to be for medical purposes.

“Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification,

or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.“

The short description is a product is seen as a medical device when: “Medical devices are products or agents which are used for medical purposes, with the exception of drugs for medical purposes.”

44

Medical devices and CE marking

A medical device needs to have a CEMarking. In the case of Cobeco, some of our products are ‘medical devices’, which means they have a CE-Marking.

The CE mark is a conformity regulation that must be applied to products that are covered by the European New Approach Directives. With this marking, the manufacturer shows that the product complies with the requirements as described in the applicable directive(s).


Notification of a Medical Device

Who is responsible for the files?

Lubricants Class I and IIa Cobeco Pharma registers the products on the portal of the Dutch Ministry of Health. To register the products a technical file is needed. This file holds all the information relating to the product. Cobeco Pharma has a complete technical file of her lubricants.

Cobeco Pharma documents all product files at their company. The procedure for CE marking files, by law, is the file must be available at the location of the manufacturer. When authorities have questions they can contact the local ministry of Health or the manufacturer.

Classification and related legislation / registration

All products bearing the CE marking have free access to the entire market within the European Economic Area. Products that are not in compliance with the directives and do not bear the CE marking, are not permitted to be traded or put into use within the European Economic Area.

Our medical devices Lubricants Class I and IIa Cobeco Pharma registers lubricants as a medical device as class I and from Q1 2019 as class IIa. Lubricants are classified as medical device, when used for medical purposes and according intended use. It is possible to have a private label lubricant with your product name on the label.

After the registration is completed, you will receive a Declaration of Conformity and a Declaration of Equivalence. Depending on the country where the lubricant is sold, for private label products it could be necessary that the customer also notifies the product at the local authorities together with the declaration(s).

All products bearing the CE marking have free access to the entire market within the European Economic Area

Medical devices and CE marking

45


Classification and related legislation / registration

Food supplements & health products Definition Health products are products of which the primary function is related to the health. Food supplements are the most important. Vitamins and minerals are the most known food supplements, but also products with other substances as amino acids, herbs, fish oil, fibres, glucosamine, cranberry, probiotic etcetera, are food supplements (according to Dutch legislation). This group ‘other substances’ is a big group of ingredients for the food supplements.

The definition:

46

Food supplements & health products

‘Food supplements’:

‘Herbal preparations’:

'food products that are meant in addition to the normal diet, that have a concentrated source of one or more nutrients, or other substances with a nutritional or physiological effect; and are brought into a pre-dosed form on the market, namely as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders to be taken in small measured quantities.'

'A herbal preparation is a herbal substance, which can be or cannot be edited, and can be consumed by human, also meaning herbal extracts. Herbal extracts also can be food supplements.'


Classification and related legislation / registration

Legislation of notification Food supplements belong to food and have to comply to the legislation of â&#x20AC;&#x2DC;Warenwetâ&#x20AC;&#x2122;, which is the Dutch Ministry of Health. Food supplements can look like medicine but are not medicine (according to Dutch legislation). For food and for food supplements a medical purpose is not allowed to claim for the product.

The legislation of food supplements can be different in several countries. Our assortment of food supplements is suitable for divers markets, inside and outside the European Union.

Notification or registration is not mandatory for the countries the Netherlands and United Kingdom amongst others. When registration is requested, Cobeco Pharma can supply you with production documentation.

Our assortment of food supplements is suitable for divers markets, inside and outside the European Union

Food supplements & health products

47


Notification & conformity

Notification & conformity Cobeco Pharma can provide you with documents regarding the notification or conformity of your private label product. In this section youâ&#x20AC;&#x2122;ll find the examples of the documents Cobeco Pharma can supply you with regarding your private label product. The different classification of products requires different documents of notification or registration. Besides this it depends on which procedure you choose.

48

Notification & conformity


Medical Device classification products

Notification in CPNP register for cosmetics

Registration letter Ministry of Health

When the notification in the CPNP register is finished, it is confirmed with a document of notification with CPNP notification number. This notification number shows that the cosmetic product is successfully registered at the CPNP register.

A registration letter is a letter that states that the Ministry of Health has registered a medical device CE marked product.

Product information file for cosmetics Each cosmetic product needs to have a product information file. If you decide to let Cobeco Pharma arrange the product information file, you will receive a completed file. This file contains all needed information regarding the product and production, safety and assessment, and ingredient information.

Food supplements

Notification & conformity

Cosmetic classification products

Regarding food supplements it depends on the country where the products need to be marketed. Cobeco Pharma can provide you with production documentation for this process.

Declaration of conformity & Equivalence Declarations of conformity & equivalence are documents that are issued by Cobeco Pharma to declare that your product with CE marking has met the required quality standards.

0050

Cosmetic classification products / Medical Device classification products / Food supplements

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Export documents

Export documents When you are located outside the EU and we need to export your product, specific documents can be requested by the authorities to notify and/or register your product in your own country. In some cases when there is a trade agreement between your country and the Netherlands, there are documents available that will save import duties.

When products are being exported, all required documents will be needed. We could help you out with the documents you request. For certain documents we will make a surcharge because of the costs we need to make.

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Production certificate and storage documents

Production certificate and storage documents Certificate of Analysis A Certificate of Analysis is an authenticated document that is issued by the Quality Control Department that ascertains that the product has met its product specification and quality.

Information Data Sheet (IDS) An Information Data Sheet is a document that holds the relevant information regarding the safety. It is intended to provide professional users with information regarding safe storage and transport. It includes information such as physical data, storage, disposal, protective equipment, and spill-handling procedures.


When you are located outside the EU and we need to export your product, specific documents can be requested by the authorities to notify and/or register your product in your own country. When products will be exported, all the required documents will be needed.

Export documents

Export Documents for registration and shipment Free Sale

Certificate of Origin (CoO)

(cosmetic and food supplements) A certificate of origin (CoO) is a document that indicates the origin of the product. A CoO proves in which country a product is made. Without CoO you may encounter difficulties if you want to import products in a particular country. Some countries outside the EU are asking for a CoO for trade and political measurements, such as boycotts, import restrictions and import quotas. Also, in some countries the customs apply the general duties to be paid or the MFN rate (most favoured rate) for products accompanied with a CoO. That could mean, you pay less taxes or nothing at all.

A Free Sale Certificate (FSC) is meant to register a particular product in a third country (non-EU country and can be used for this purpose only. This document is not related to a shipment of products. If a FCS is required depends on the country. Ask your local authorities if you need a FCS before we export your order. A Free Sale Certificate states that the products are free trade in the EU. They must also comply to EU legislation. It can take about 15-20 days to request this document for new product at authorities.

We could help you out with all required documents that will be needed Export Documents for registration and shipment

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Export documents

Export statement (cosmetic and food supplements)

Export statement & free sale (medical devices)

An export statement provides detailed information regarding the shipment of products. Mentioned are kind of products, weight, article number, etcetera. The certificate contains all the information necessary for customs, if they might choose to check the products.

Export of medical devices for non-European countries may require an export declaration (Free Sales Certificate). This certificate states that the listed products in Europe are freely tradable on the market. The Free Sale and Export Statement are both in the same document for medical devices. It can take more than 30 days for a request of this document at authorities.

When requested a Free Sale that was necessary for registration, then the Export Statement is obligated to request shipment for each order. In case Free Sale will not be necessary, it is important to check if customs of your country requires an Export Statement. It can take about 7 days to request this document at authorities (or 15 -20 in case new products not notified before).

specific documents can be requested by the authorities

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Other export shipment documents

Other export shipment documents EUR.1 (for countries with a trade agreement) An EUR.1 is valid in countries that are covered by a EU trade agreement. With an EUR.1 certificate, the importer in the country of destination is entitled to pay less import of even no import duties. An EUR.1 certificate is only used for products of preferential origin. The use of a EUR.1 is not mandatory. Clients are interested in it, because it can involve a financial advantage. In some cases there is little difference between the general and preferential rate, making it hardly worth the effort to apply for a EUR.1 certificate. When the products of preferential origin in the shipment are of less value than EUR 6.000,- then an EUR.1 certificate is not used.


Some countries require legalisation of documents. In many cases, a legalization of sales invoices is only needed by the Chamber of Commerce. In some cases legalization by Embassy is required.

Chamber of Commerce

Embassy

The Chamber of Commerce (CoC) verifies the name and signature on the document and legalizes this signature. After authentication, you the document will be returned to you, with the required legalization stamp of the Chamber of Commerce on it.

For certain countries legalization is required by the Embassy and/or the Ministry of Foreign Affairs. Different embassies charge different costs and how long the legalization takes depends on the country (between 1 until 10 working days).

Export documents

Legalisation

...approved!

Legalisation

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Quality control

Quality control

At Cobeco Pharma we stand for quality. We put all the effort needed in it, to make sure that our products, ingredients and packaging meet the most stringent requirements. To be able to guarantee this, Cobeco Pharma has a quality control department that is checking every quality procedure and assures all requirements meet our quality standards for developing food supplements, cosmetic products and medical devices and packaging to be brought to market in European and outside. Beside this, Cobeco Pharma is a member of various associations and is working according quality assurance system principles.

NPN - Cobeco Pharma is a member of

HACCP - Cobeco Pharma pursues a

the Dutch trade organisation Natuur & gezondheidsproducten Nederland (NPN). This organisation and its affiliates stand for the promotion of quality and safety in the field of food supplements.

quality assurance policy based on the Hazard Analysis of Critical Control Points (HACCP). The entire production process is being monitored to detect potential food safety dangers by the HACCP system.

ISO13485 - ISO13485 is a standard for medical devices and a quality management system in accordance to which Cobeco Pharma operates and produces.

GMP - Products have to be produced

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NCV - Cobeco Pharma is a member of

Sedex - Cobeco Pharma is a member

the Dutch Cosmetics Assosiation called Nederlandse Cosmetica Vereniging (NCV). The NCV is the official trade organization of manufacturers and importers of cosmetics.

of SEDEX, a non-profit membership organisation dedicated to create improvement in responsible and ethical business practices in global supply chains.

Quality control

in accordance to strict requirements. These requirements are called the ‘Good Manufacturing Practice’ (GMP). Cobeco produces in accordance to the guidelines of GMP. Our staff is especially being trained to produce our products. Because of that, there have been a quality control system and a special designed manufactory.


A selection from our wide range of products

Lubricants

Sexual aid / gel creams

Sexual aid / foodsup. tab/cap

Intimate hygiene

100% Natural Lubricant Waterbased Butter Lubricant Cream white lubricant Ice Waterbased Lubricant Lubricant 2-1 Waterbased Lubricant Aloe vera Lubricant anal waterbased (thick) Lubricant Cannabis Lubricant Energy/Guarana Lubricant Waterbased Lubricant Waterbased Cherry Lubricant Waterbased Chocolate Lubricant Waterbased Extra thick Lubricant Waterbased Extra think white Lubricant Waterbased Forest Fruit Lubricant Waterbased PassionFruit Lubricant Waterbased Pina Colada Lubricant Waterbased Strawberry Lubricant Waterbased Vanilla Lubricant Waterbased Warming Lubricant Waterbased White Color Silicone Lubricant neutral Silicone Lubricant scented Silicone Lubricant Cooling Silicone Lubricant warming

Aftercare Gel Bikini Blk Breast cream Bust gel Buttocks Gel Delay Cream Delay Gel - Clear Erection cream Male Enhancement lotion Oral Gel Strawberry Oral Gel Tropical Oral Gel Vanille Sensual cream Skin Lightenening cream Stimulation gel men Stimulation gel women Vaginal Gel

Bust Tabs Chocolate delight tabs Cum enhancement virility caps Energy metabolism Enhancement caps white Male enhancement caps Male enhancement tabs 65 Male erection aid tabs Male tabs 27 Psychological functions tabs Virility caps Virility red tabs

Intimate wipes Penis intimate cleaner Soap-free intimate wash gel

Sexual aid / liquids Delay Spray Spray Delay Cooling Spray Delay Strawberry Spray Delay Warming

Sexual aid / foodsup. liquids Cum enhancement liquid Guarana liquid Rush herbal liquid Spanish Fly Formula Spanish Fly Formula Muira Puima Spanish Fly Formula Apple Spanish Fly Formula Banana Spanish Fly Formula Blackberry Spanish Fly Formula Caramel Spanish Fly Formula Chocolate Spanish Fly Formula Cola Spanish Fly Formula Kiwi Spanish Fly Formula Pineapple Spanish Fly Formula Raspberry Spanish Fly Formula Strawberry

Assortment

Assortment

Massage oils / candles Massage oil Balance / Relax Massage oil Exlusive / Love Massage oil Harmony Massage oil Joyfull / Delight Massage oil Neutral Massage oil Stimulating Citrus Massage oil Warming

Sachets Sachets wet wipes

Maintentance Latex Leather Spray Talcum powder Toycleaner Toycleaner lemon Washing soap - NEW 80s Disinfectant - NEW

Assortment

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producer and wholesaler of pharmaceutical, cosmetic and stimulating products cobeco pharma manufacturing bv • hertzstraat 2 • 2652 xx berkel en rodenrijs • the netherlands t +31 (0)10 290 09 91 • sales@cobeco-privatelabel.nl • www.cobeco.nl • shop.cobeco.nl/private-label

EN/08-2018

Cobeco Private Label 08-2018  
Cobeco Private Label 08-2018  
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