Tjaša Grum , CE.way Regulatory Consultants Ltd.01.16.19
The Brexit agreement was rejected by the UK Parliament yesterday, which makes a “no deal” scenario closer to reality than ever. However, the negotiations are still ongoing, and many options remain open, including a possibility of a new referendum on Brexit, which would postpone the withdrawal date, or even result in no Brexit at all. Today, UK Prime Minister Theresa May's government won a confidence vote in Parliament, but the path forward for Brexit remains unclear.
If Brexit were to take place as planned, with its March 30, 2019 withdrawal date,the United Kingdom (UK) will be considered a third country as it will no longer be a member of the European Union. EU treaties define a “third country” as having “deep and special partnerships” with the EU, such as Norway and Switzerland, but it will never enjoy the benefits of a member state. Brexit will have an impact on many industries, and the cosmetic industry is no exception. There are some legal repercussions, which need to be taken into account when the UK leaves the EU. Since the UK will no longer be a member state of the EU, the EU legislation regarding cosmetic products, in particular, Regulation (EC) No 1223/2009, will no longer be applicable. Companies both in the EU and in the UK are wondering which changes this will bring to their business operations. The EU Commission recently published a Notice to stakeholders: Withdrawal of the United Kingdom and EU rules in the field of cosmetic products, which provides some clarifications.
Every cosmetic product that is placed on the EU market needs a legal or a natural person within the EU to act as a responsible person (RP). TheRP is, as the name would suggest, responsible for ensuring the product is compliant with the requirements set out in Regulation (EC) No 1223/2009.
Current Requirements: According to Regulation (EC) 1223/2009, if cosmetic products are manufactured within the EU, the RP is by default the manufacturer or can designate another person who is established within the EU to be the RP. However, for cosmetic products imported from a third country, the importer becomes the RP by default, or again, can designate another person established within the EU, to be the RP. In both cases, the designation has to be made by written mandate.
Post-Brexit: Since the UK will soon become a third country, the currently established RPs in the UK will no longer be able to act as the RPs for cosmetic products marketed in the EU. In this case, the manufacturer/importer should ensure that as of 30 March 2019, the RP is established in one of the remaining 27 EU Member States. For cosmetic products manufactured in the UK, the EU importer becomes the RP (by default) or can designate another person established within the EU-27, to become the RP. The same applies to cosmetic products, which are manufactured in another third country and then imported to the UK and subsequently imported into the EU.
Prior toplacing the cosmetic product on the EU market, the RPs have to notify the cosmetic product via an online notification portal called the Cosmetic Product Notification Portal (CPNP). To do so, they must also compile all of the necessary documents, specifications and tests, called the product information file (PIF), for each of the products, as requested by the Regulation (EC) 1223/2009. PIF has to be readily accessible at the RP’s address, in either electronic or any other format.
Post-Brexit: After March 30, 2019, PIF has to be made available at the address of the RP based in one of the remaining EU-27 countries. It must be noted that PIF has to be prepared in a language easily understood by the competent local authority in a Member State where the RP is based. This means that the PIF may have to be translated into a language other than English.
RPs established in the UK can transfer notifications of existing cosmetic products to a new (future) EU-27 RP. The latter will be able to edit the notification and make all the necessary changes and updates (e.g. the name and address of the new RP, contact person, updated label and photo of the product). However, this notification transfer is only possible until the withdrawal date. After that, the former, UK-based RP will no longer have access to the CPNP, so if the CPNP notification transfer is not made until the withdrawal date, the new RP will have to make a completely new CPNP notification.
The name and the address of the RP must be written on the label of cosmetic products. If Brexit occurs, any UK based RP name and address will have to be replaced by the EU-27 RP’s name and address on the cosmetic products marketed in the EU. It is important to add, that for cosmetic products imported into the EU, the country of origin needs to be indicated on the label of these products. Thus, as of the withdrawal date, the cosmetic products manufactured in the UK and placed on the EU market, need to have a country of origin written on their label.
Many businesses are wondering what requirements for cosmetic products sold on the UK market are going to be after Brexit. In the light of the recent events, there is a high probability that the UK leaves the EU without any agreement and no transition period, which would be called a “no deal” scenario. There is still some time left for negotiations and possible new deals or even a new referendum on Brexit, but after the recent rejection of the Brexit deal by the UK parliament, the UK leaving the EU without any deal remains highly likely. In this kind of situation, according to the UK guidance document called “Appointing nominated persons to your business if there’s no Brexit deal”, as of withdrawal date, cosmetic products that are sold in the UK and have an EU-27 RP will need to have a new, UK-based RP. Therefore, it is possible, that businesses will need to appoint a UK-based RP in order to sell cosmetic products in the UK.
Who is affected? The UK is the second largest EU market for cosmetic products, and in 2017 it was the third biggest country in the EU by the number of RPs according to CTPA (in 2017 there were 6120 EU RPs based in the UK) with 180,000 notifications made by the RPs based in the UK (http://www.ctpa.org.uk/content.aspx?pageid=516). Based on these figures it is clear that Brexit and all of the pre-mentioned consequences that it will bring will affect many cosmetic product manufacturers, importers and distributors.
About CE.way
CE.way Regulatory Consultants also acts as a professional, third party, EU cosmetics RP. Since CE.way’s offices are based in Ireland and Slovenia, CE.way will be able to act as the EU RP for cosmetic products also after Brexit. If any company that has an EU RP currently based in the UK would decide to transfer this task to CE.way, they also won’t have to translate their PIFs as English is considered a language easily understood by the competent local authority both in Ireland and in Slovenia. If products sold on the UK market will indeed require a separate RP based in the UK, CE.way will most likely establish an office also in the UK in order to be able to serve its clients selling cosmetics there.
If Brexit were to take place as planned, with its March 30, 2019 withdrawal date,the United Kingdom (UK) will be considered a third country as it will no longer be a member of the European Union. EU treaties define a “third country” as having “deep and special partnerships” with the EU, such as Norway and Switzerland, but it will never enjoy the benefits of a member state. Brexit will have an impact on many industries, and the cosmetic industry is no exception. There are some legal repercussions, which need to be taken into account when the UK leaves the EU. Since the UK will no longer be a member state of the EU, the EU legislation regarding cosmetic products, in particular, Regulation (EC) No 1223/2009, will no longer be applicable. Companies both in the EU and in the UK are wondering which changes this will bring to their business operations. The EU Commission recently published a Notice to stakeholders: Withdrawal of the United Kingdom and EU rules in the field of cosmetic products, which provides some clarifications.
Responsible Person
Every cosmetic product that is placed on the EU market needs a legal or a natural person within the EU to act as a responsible person (RP). TheRP is, as the name would suggest, responsible for ensuring the product is compliant with the requirements set out in Regulation (EC) No 1223/2009.
Current Requirements: According to Regulation (EC) 1223/2009, if cosmetic products are manufactured within the EU, the RP is by default the manufacturer or can designate another person who is established within the EU to be the RP. However, for cosmetic products imported from a third country, the importer becomes the RP by default, or again, can designate another person established within the EU, to be the RP. In both cases, the designation has to be made by written mandate.
Post-Brexit: Since the UK will soon become a third country, the currently established RPs in the UK will no longer be able to act as the RPs for cosmetic products marketed in the EU. In this case, the manufacturer/importer should ensure that as of 30 March 2019, the RP is established in one of the remaining 27 EU Member States. For cosmetic products manufactured in the UK, the EU importer becomes the RP (by default) or can designate another person established within the EU-27, to become the RP. The same applies to cosmetic products, which are manufactured in another third country and then imported to the UK and subsequently imported into the EU.
CPNP and PIF
Prior toplacing the cosmetic product on the EU market, the RPs have to notify the cosmetic product via an online notification portal called the Cosmetic Product Notification Portal (CPNP). To do so, they must also compile all of the necessary documents, specifications and tests, called the product information file (PIF), for each of the products, as requested by the Regulation (EC) 1223/2009. PIF has to be readily accessible at the RP’s address, in either electronic or any other format.
Post-Brexit: After March 30, 2019, PIF has to be made available at the address of the RP based in one of the remaining EU-27 countries. It must be noted that PIF has to be prepared in a language easily understood by the competent local authority in a Member State where the RP is based. This means that the PIF may have to be translated into a language other than English.
RPs established in the UK can transfer notifications of existing cosmetic products to a new (future) EU-27 RP. The latter will be able to edit the notification and make all the necessary changes and updates (e.g. the name and address of the new RP, contact person, updated label and photo of the product). However, this notification transfer is only possible until the withdrawal date. After that, the former, UK-based RP will no longer have access to the CPNP, so if the CPNP notification transfer is not made until the withdrawal date, the new RP will have to make a completely new CPNP notification.
Labelling
The name and the address of the RP must be written on the label of cosmetic products. If Brexit occurs, any UK based RP name and address will have to be replaced by the EU-27 RP’s name and address on the cosmetic products marketed in the EU. It is important to add, that for cosmetic products imported into the EU, the country of origin needs to be indicated on the label of these products. Thus, as of the withdrawal date, the cosmetic products manufactured in the UK and placed on the EU market, need to have a country of origin written on their label.
’No Deal’ Scenario
Many businesses are wondering what requirements for cosmetic products sold on the UK market are going to be after Brexit. In the light of the recent events, there is a high probability that the UK leaves the EU without any agreement and no transition period, which would be called a “no deal” scenario. There is still some time left for negotiations and possible new deals or even a new referendum on Brexit, but after the recent rejection of the Brexit deal by the UK parliament, the UK leaving the EU without any deal remains highly likely. In this kind of situation, according to the UK guidance document called “Appointing nominated persons to your business if there’s no Brexit deal”, as of withdrawal date, cosmetic products that are sold in the UK and have an EU-27 RP will need to have a new, UK-based RP. Therefore, it is possible, that businesses will need to appoint a UK-based RP in order to sell cosmetic products in the UK.
Who is affected? The UK is the second largest EU market for cosmetic products, and in 2017 it was the third biggest country in the EU by the number of RPs according to CTPA (in 2017 there were 6120 EU RPs based in the UK) with 180,000 notifications made by the RPs based in the UK (http://www.ctpa.org.uk/content.aspx?pageid=516). Based on these figures it is clear that Brexit and all of the pre-mentioned consequences that it will bring will affect many cosmetic product manufacturers, importers and distributors.
About CE.way
CE.way Regulatory Consultants also acts as a professional, third party, EU cosmetics RP. Since CE.way’s offices are based in Ireland and Slovenia, CE.way will be able to act as the EU RP for cosmetic products also after Brexit. If any company that has an EU RP currently based in the UK would decide to transfer this task to CE.way, they also won’t have to translate their PIFs as English is considered a language easily understood by the competent local authority both in Ireland and in Slovenia. If products sold on the UK market will indeed require a separate RP based in the UK, CE.way will most likely establish an office also in the UK in order to be able to serve its clients selling cosmetics there.
