### the creation of unitary patent protection should be achieved by giving unitary effect to european patents in the post - grant phase by virtue of this regulation and in respect of the participating member states . the main feature of european patents with unitary effect should be their unitary character , i . e . providing uniform protection and having equal effect in all participating member states . consequently , a european patent with unitary effect should only be limited , licensed , transferred , revoked or lapse in respect of all the participating member states . to ensure the uniform substantive scope of protection conferred by unitary patent protection , only european patents that have been granted for all the participating member states with the same set of claims should benefit from unitary effect . however , to ensure legal certainty in the event of a limitation or revocation on the ground of lack of novelty pursuant to article 54 epc , the limitation or revocation of a european patent with unitary effect should take effect only in respect of the participating member state designated in the earlier european patent application as published . finally , the unitary effect attributed to a european patent should have an accessory nature and should cease to exist or be limited to the extent that the basic european patent has been revoked or limited . ### the creation of unitary patent protection should be achieved by giving unitary effect to european patents in the post - grant phase by virtue of this regulation and in respect of all the participating member states . the main feature of european patents with unitary effect should be their unitary character , i . e . providing uniform protection and having equal effect in all participating member states . consequently , a european patent with unitary effect should only be granted , limited , transferred or revoked , or lapse or become subject to law enforcement , in respect of all the participating member states . it should be possible for a european patent with unitary effect to be licensed in respect of the whole or part of the territories of the participating member states . to ensure the uniform substantive scope of protection conferred by unitary patent protection , only european patents that have been granted for all the participating member states with the same set of claims should benefit from unitary effect . finally , the unitary effect attributed to a european patent should have an accessory nature and should cease to exist or be limited to the extent that the basic european patent has been revoked or limited .


### the part of the collected renewal fees to be distributed to the participating member states referred to in article 12 shall be 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect minus the costs associated with the administration of the unitary patent protection referred to in article 12 . ### the european patent office shall retain 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect . the remaining amount shall be distributed to the participating member states in accordance with the share of distribution of the renewal fees set in accordance with article 12 .


### the part of the collected renewal fees to be distributed to the participating member states referred to in article 12 shall be 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect minus the costs associated with the administration of the unitary patent protection referred to in article 12 . ### the european patent office shall retain 50 percent of the renewal fees referred to in article&#160 ; 14 paid for european patents with unitary effect . the remaining amount shall be distributed to the participating member states in accordance with the share of distribution of the renewal fees set in accordance with article 12 .


### acts as covered by the farmers privilege pursuant to article 14 of regulation no . 2100 / 94 which applies mutatis mutandis ; ### the use by a farmer of the product of his crop for propagation or multiplication on his own holding , provided that the reproductive vegetable material was sold or otherwise commercialised by the patent proprietor or with his consent to the farmer for agricultural purposes . the scope and the detailed methods of such use are laid down in article 14 of regulation no 2100 / 94 ;


### not later than six years from the date on which the first european patent with unitary effect takes effect in the territories of the participating member states , the commission shall present to the council a report on the operation of this regulation and , where necessary , make appropriate proposals for amending it . subsequent reports on the operation of this regulation shall be presented by the commission every six years . ### not later than three years from the date on which the first european patent with unitary effect takes effect in the territories of the participating member states , the commission shall present to the european parliament and the council a report on the operation of this regulation and , where necessary , make appropriate proposals for amending it . subsequent reports on the operation of this regulation shall be presented by the commission every five years .


### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently . ### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for the enforcement of this regulation and for other patent and innovation - related purposes , including for the provision of advice and support to small and medium - sized enterprises . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently .


### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently . ### renewal fees should be paid to the european patent organisation . the european patent office shall retain an amount to cover the expenses generated at the european patent office in carrying out tasks in relation to the unitary patent protection in accordance with article 146 epc . the remaining amount shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market and should guarantee a minimum amount to be redistributed to each participating member state in order to maintain a balanced and sustainable functioning of the system . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity established on the basis of the european innovation scoreboard and having acquired membership of the european patent organisation relatively recently .


### the size of the market expressed in the number of population , ### the size of the market , while ensuring a minimum amount to be distributed to each participating member state ,


### the lawyer shall have the right to check the conditions in which the suspect or accused person is detained and to this end shall have access to the place where the person is detained . ### the lawyer shall have access the place where the suspect or accused person is detained and shall have the right to submit to the competent judicial authority an application for authorisation to check the conditions of detention .


### the lawyer shall have the right to be present at any other investigative or evidence - gathering act at which the suspect or accused person’s presence is required or permitted as a right , in accordance with national law , unless this would prejudice the acquisition of evidence . ### member states shall determine in their national law in respect of which investigative or other evidence - gathering acts at which the suspect or accused person’s presence is required or – in accordance with national law – permitted as a right , the suspect or accused person has – in accordance with procedures in national law – the right for his lawyer to be present .


### the lawyer shall have the right to be present at any questioning and hearing . he shall have the right to ask questions , request clarification and make statements , which shall be recorded in accordance with national law . . ### the suspect or accused person shall have the right for his lawyer to be present at any law enforcement or judicial authorities interview and at any hearing . . he shall have the right to ask questions , request clarification and make statements , which shall be recorded in accordance with national law .


### the lawyer shall have the right to be present at any other investigative or evidence - gathering act at which the suspect or accused person’s presence is required or permitted as a right , in accordance with national law , unless this would prejudice the acquisition of evidence . ### the lawyer shall have the right to be present at any other investigative or evidence gathering act , save where and only in so far as the person carrying out that investigative or evidence gathering act reasonably believes that evidence will be altered , removed or destroyed pending the lawyer ' s arrival .


### this directive applies from the time a person is made aware by the competent authorities of a member state , by official notification or otherwise , that he is suspected or accused of having committed a criminal offence until the conclusion of the proceedings , which is understood to mean the final determination of the question whether the suspected or accused person has committed the offence , including , where applicable , sentencing and the resolution of any appeal . ### this directive applies from the time a person is made aware by the competent authorities of a member state , by official notification or otherwise , that he or she is suspected or accused of having committed a criminal offence , or from the time he or she is deprived of their liberty , until the conclusion of the proceedings , which is understood to mean the final determination of the question whether the suspected or accused person has committed the offence , including , where applicable , sentencing and the resolution of any appeal .


### proposal for a directive of the european parliament and of the council on the right of access to a lawyer in criminal proceedings and on the right to communicate upon arrest ### proposal for a directive of the european parliament and of the council on the right of access to a lawyer in criminal proceedings and on the right to communicate in the event of arrest


### member states shall ensure that the confidentiality of meetings between the suspect or accused person and his lawyer is guaranteed . they shall also ensure the confidentiality of correspondence , telephone conversations and other forms of communication permitted under national law between the suspect or accused person and his lawyer . ### member states shall ensure that the confidentiality of all meetings between a person to whom article 2 applies and his lawyer is guaranteed . they shall also ensure the confidentiality of correspondence , telephone conversations and other forms of communication permitted under national law between the suspect or accused person and his lawyer .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure for intense muscular effort and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated acts , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation .


### ‘ food for special medical purposes’ means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . ### ‘ food for special medical purposes’ means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . food for special medical purposes also includes very low calorie diets , which correspond to a total diet replacement under 800 kcal .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes , and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 . in addition , the concept of ' specialised nutrition ' should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market under current union legislation .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for foods for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of regulation no 41 / 2009 . in addition , the statement ‘ gluten - free’ may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of regulation no 41 / 2009 which do not allow the use of the statement ‘ very low gluten’ for these foods . such foods for specialized nutrition intended for people intolerant to gluten should be maintained in this regulation , as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for foods for special dietary use for persons intolerant to gluten . also the conditions of use of the claim ‘ gluten - free’ for foods for normal consumption should be maintained in the regulation no 41 / 2009 .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec and regulation no 41 / 2009 , as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods referred to in article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### currently , the statements ' gluten - free ' and ' very low gluten ' may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ' gluten - free ' and ' very low gluten ' and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ' gluten - free ' and ' very low gluten ' may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . the recently adopted regulation no 1169 / 2011 on the provision of food information to consumers provides for the adoption by the commission of implementing acts regulating voluntary information on the possible and unintentional presence in food of a substance causing allergies or intolerances . for reasons of coherence and simplification of the legal framework , the commission should be granted a mandate under regulation no 1169 / 2011 to also adopt implementing acts regulating voluntary information on the absence or reduced presence in food of substances causing intolerances , such as gluten and lactose , and to withdraw commission regulation no 41 / 2009 . it is necessary that the fic regulation is amended to that effect and that the required implementing provisions be adopted by the commission prior to the entry into application of this regulation . the implementing act concerned should maintain the statements ' gluten - free ' and ' very low gluten ' on food and their associated conditions of use as currently regulated under regulation no 41 / 2009 , and hence provide for the same level of consumer protection .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labeling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . gluten - free foods are the only food source for coeliac disease sufferers . the composition of foods is decisive in managing the condition . gluten - free foods should therefore come under the scope of this regulation .


### the dissemination of any useful information or recommendations with reference to the categories of food referred to in article 1 may be made exclusively by persons having qualifications in medicine , nutrition , pharmacy or other professionals responsible for maternal and child health care . ### paragraph 3 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine , nutrition and pharmacy or other professionals responsible for maternal and child health care .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for foods for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of regulation no 41 / 2009 . in addition , the statement ‘ gluten - free’ may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of regulation no 41 / 2009 which do not allow the use of the statement ‘ very low gluten’ for these foods . such foods for specialized nutrition intended for people intolerant to gluten should be maintained in this regulation , as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for foods for special dietary use for persons intolerant to gluten .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directives 2006 / 141 / ec , 2006 / 125 / ec and 1999 / 21 / ec , and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### the delegation of power referred to in article 10 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the delegation of power referred to in article 10 shall be conferred on the commission for a period of five years from the date of entry into force of this regulation . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . provided this report has been drawn up , the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such an extension not later than three months before the end of each period .


### it distributes vehicles or provides repair , maintenance or testing services for vehicles ; ### it builds or distributes vehicles or provides repair , maintenance or testing services for vehicles ;


### it has a good reputation and has the requisite professional competence . ### it has the requisite professional competence .


### this regulation shall apply to the following vehicles : ### this regulation shall apply to registration of the following motor vehicles :


### in implementing the regulation , coherence shall be ensured with other areas of union ' s external action and with other relevant union policies . particular attention shall be given to ensure smooth transition between relief , rehabilitation and development . 2 . the commission and the member states shall cooperate to improve the consistency and coherence between relevant national volunteering schemes and the actions of the eu aid volunteers . 3 . the union shall foster cooperation with relevant international organisation , in particular the united nations , and other humanitarian aid partners in implementation of the actions of the eu aid volunteers . ### in implementing the regulation , coherence and complementarity shall be ensured with other areas of the union ' s external action and with other relevant union policies , particularly humanitarian aid policy , development cooperation policy and the union ' s civil protection mechanism , in order , in particular , to ensure the added value of the actions of the eu aid volunteers initiative . particular attention shall be given to ensure smooth transition between relief , rehabilitation and development . 2 . the commission and the member states shall cooperate to improve the consistency and coherence between relevant national volunteering schemes and the actions of the eu aid volunteers . 3 . the union shall foster cooperation with relevant international organisation , in particular the united nations , and other humanitarian aid partners in implementation of the actions of the eu aid volunteers initiative .


### budgetary resources the financial reference amount for the implementation of this regulation for the period 2014 to 2020 shall be eur 239 . 100 . 000 at current prices . if necessary , appropriations could be entered in the budget beyond 2020 to cover similar expenses , in order to enable the management of actions not yet completed by 31 december 2020 . ### financial reference amount the financial reference amount for the implementation of this regulation for the period 2014 to 2020 shall be eur [ . . . ] at current prices . if necessary , payment appropriations could be entered in the budget beyond 2020 to cover similar expenses , in order to enable the payment management of actions not yet completed by 31 december 2020 .


### article 8 actions of the eu aid volunteers the eu aid volunteers shall pursue the objectives referred to in articles 3 and 7 through the following types of actions : – development and maintenance of standards regarding candidate and eu aid volunteers ; – development and maintenance of a certification mechanism for sending and hosting organisations ; – identification and selection of candidate volunteers ; – establishment of a training programme and support for training and apprenticeship placements ; – establishment , maintenance and updating of a register of eu aid volunteers ; – deployment of eu aid volunteers in third countries for humanitarian aid activities and operations ; – capacity building of hosting organisations ; – establishment and management of an eu aid volunteers ' network ; – communication , awareness raising and visibility ; – ancillary activity that furthers the accountability , transparency and effectiveness of the eu aid volunteers . ### article 8 actions of the eu aid volunteers initiative the eu aid volunteers initiative shall pursue the objectives referred to in articles 3 and 7 through the following types of actions : – development and maintenance of standards regarding candidate and eu aid volunteers ; – development and maintenance of a certification mechanism for sending and hosting organisations ; – identification and selection of candidate volunteers ; – establishment of a training programme and support for training and apprenticeship placements ; – establishment , maintenance and updating of a register of eu aid volunteers ; – deployment of eu aid volunteers in third countries for humanitarian aid activities and operations ; – capacity building of hosting organisations ; – recognition and acknowledgement of the experience of volunteers who have successfully participated in the eu aid volunteers initiative ; – establishment and management of an eu aid volunteers ' network ; – communication , awareness raising and visibility ; – ancillary activity that furthers the accountability , transparency and effectiveness of the eu aid volunteers initiative .


### the training programme shall include an assessment of the candidate volunteers ' readiness to be deployed in humanitarian aid operations . ### the training programme shall include an assessment of the candidate volunteers ' readiness to be deployed in humanitarian aid operations and to help ensure security and safety when deployed .


### the eu aid volunteers shall pursue the following operational objectives : ### the eu aid volunteers initiative shall pursue the following operational objectives :


### the union ' s humanitarian aid is delivered in situations where other instruments related to development cooperation , crisis management and civil protection operate . the eu aid volunteers should work in a coherent and complementarity manner with relevant policies and instruments in order to make the most effective use of these instruments while systematically promoting humanitarian principles and long - term development goals . synergies of the actions of the eu aid volunteers should be sought with the union civil protection mechanism , the emergency response centre established by decision xx / xxxx and with the eeas and the eu delegations in order to coordinate the union ' s response to humanitarian crises in third countries . ### the union ' s humanitarian aid is delivered in situations where other instruments related to development cooperation , crisis management and civil protection operate . the eu aid volunteers initiative should work in a coherent and complementarity manner with relevant policies and instruments in order to make the most effective use of these instruments while systematically promoting humanitarian principles and long - term development goals . synergies of the actions of the eu aid volunteers initiative should be sought in particular with the union ' s humanitarian aid policy , development cooperation policy and the union civil protection mechanism , the emergency response centre established by decision xx / xxxx and with the eeas and the eu delegations in order to coordinate the union ' s response to humanitarian crises in third countries .


### building the capacity of hosting organisations and foster volunteering in third countries progress towards the achievement of this operational objective shall be assessed on the basis of indicators , such as : – the number and type of capacity building actions ; – the number of third country staff and volunteers participating in the capacity building actions . ### building the capacity of hosting organisations and foster volunteering in third countries progress towards the achievement of this operational objective shall be assessed on the basis of indicators , such as : – the number and type of capacity building actions in third countries ; – the number of third country staff and volunteers participating in the capacity building actions ; – the degree of satisfaction of staff of the hosting organisations and volunteers from third countries participating in capacity building actions , with regard to the quality of the actions carried out .


### improvement of the skills and competences of volunteers in the field of humanitarian aid and the conditions under which they are working progress towards the achievement of this operational objective shall be assessed on the basis of indicators , such as : – the number of volunteers trained and the quality of the training on the basis of the reviews and level of satisfaction ; – the number of certified sending organisations applying the standards for deployment and management of eu aid volunteers . ### improvement of the skills , knowledge level and competences of volunteers in the field of humanitarian aid and the conditions under which they are working progress towards the achievement of this operational objective shall be assessed on the basis of indicators , such as : – the quality of the training of volunteers on the basis of the reviews and level of satisfaction ; – the number of certified sending organisations applying the standards for deployment and management of eu aid volunteers ; – the degree of satisfaction of the volunteers trained , of the sending and hosting organisations and of communities in the third countries participating in or receiving this aid , with regard to the quality of training , level of knowledge , competences and working conditions of the volunteers ; – changes in working conditions for volunteers .


### actions of the eu aid volunteers ### actions of the eu aid volunteers initiative


### the actions of the eu aid volunteers shall be conducted in compliance with the humanitarian aid principles of humanity , neutrality , impartiality and independence . the actions of the eu aid volunteers shall respond to the need of local communities and hosting organisations and should contribute to the professionalization of the provision of humanitarian aid . the safety and security of volunteers shall be a priority . the eu aid volunteers shall promote common activities and participation of volunteers from different countries and foster joint projects and transnational partnerships between implementing organisations as referred to in article 10 . ### the actions of the eu aid volunteers initiative shall be conducted in compliance with the humanitarian aid principles of humanity , neutrality , impartiality and independence . the actions of the eu aid volunteers initiative shall respond to the need of local communities and hosting organisations and should contribute to the professionalization of the provision of humanitarian aid . the safety and security of volunteers shall be a priority . the eu aid volunteers initiative shall promote common activities and participation of volunteers from different countries and foster joint projects and transnational partnerships between implementing organisations as referred to in article 10 .


### for the entire duration of gmes initial operations , a financial envelope of eur 107m constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management should be established . it is envisaged that this financial envelope will be complemented by an amount of eur 43 million from the space theme of the seventh framework programme for research actions accompanying gmes initial operations . ### for the entire duration of gmes initial operations , a financial envelope of eur 107m constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management should be established . it is envisaged that this financial envelope will be complemented by an amount of eur 209 million from the space theme of the seventh framework programme for research actions accompanying gmes initial operations . these two sources of financing should be managed in a coordinated manner so that real progress can be made in deploying gmes services .


### the delegation of powers referred to in articles 4 and 5 and in paragraphs 1 , 2 and 3 of article 10 shall be conferred for an indeterminate period of time from the date of the entry into force of this regulation . ### the delegation of powers referred to in articles 4 and 5 and in paragraphs 1 , 2 and 3 of article 10 shall be conferred for a period of five years from . . . + . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period . _____________ + o . j . : please insert the date of entry into force of this regulation .


### a delegated act adopted pursuant to articles 4 and 5 and paragraphs 1 , 2 and 3 of article 10 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to articles 4 and 5 and paragraphs 1 , 2 and 3 of article 10 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by four months at the initiative of the european parliament or of the council .


### in special areas of conservation within the meaning of article 6 of directive 92 / 43 / eec , of article 4 of directive 2009 / 147 / ec and of article 13 of directive 2008 / 56 / ec , fishing activities shall be conducted by member states in such a way so as to alleviate the impact from fishing activities in such special areas of conservation . ### in special areas of conservation within the meaning of article 6 of directive 92 / 43 / eec , special protection areas within the meaning of article 4 of directive 2009 / 147 / ec and other marine protected areas within the meaning of article 13 of directive 2008 / 56 / ec , fishing activities shall be conducted by the member state that has designated the site&#160 ; in such a way as to avoid the deterioration of natural habitats and the significant disturbance of species for which the areas have been designated .


### multiannual plans providing for conservation measures to maintain or restore fish stocks above levels capable of producing maximum sustainable yield shall be established as a priority . ### multiannual plans providing for conservation measures to maintain or restore fish stocks above levels capable of producing maximum sustainable yield shall be established : by 2015 for all stocks of harvested species already included within recovery or management plans ; by 2015 , where possible , for all other stocks of harvested species in union waters .


### in special areas of conservation within the meaning of article 6 of directive 92 / 43 / eec , of article 4 of directive 2009 / 147 / ec and of article 13 of directive 2008 / 56 / ec , fishing activities shall be conducted by member states in such a way so as to alleviate the impact from fishing activities in such special areas of conservation . ### in special areas of conservation within the meaning of article 6 of directive 92 / 43 / eec , special protection areas within the meaning of article 4 of directive 2009 / 147 / ec and other marine protected areas within the meaning of article 13 of directive 2008 / 56 / ec , fishing activities shall be&#160 ; regulated by member states that has designated the site in such a way so as to avoid the deterioration of natural habitats and the habitats of species as well as disturbance of the species for which the areas have been designated , in so far as such disturbance and deterioration could be significant in relation to the objectives of aforementioned directives .


### multiannual plans providing for conservation measures to maintain or restore fish stocks above levels capable of producing maximum sustainable yield shall be established as a priority . ### multiannual plans providing for adaptations of the fishing mortality rate , resulting by 2015 in biomass levels of all stocks restored or maintained above levels those capable of producing maximum sustainable yield and to maintain or restore the resilience of the marine ecosystem shall be established for all fisheries before 2015 .


### non - compliance by member states with the rules of the common fisheries policy may result in the interruption or suspension of payments or in the application of a financial correction to union financial assistance under the common fisheries policy . such measures shall be proportionate to the nature , extent , duration and repetition of the non compliance . ### noncompliance by member states with the rules of the common fisheries policy shall result in the interruption or suspension of payments or in the application of a financial correction to union financial assistance under the common fisheries policy . such measures shall be proportionate to the nature , extent , duration and repetition of the non compliance .


### member states may require holders of a fishing licence for fishing vessels of 12 meters length overall or more flying their flag to contribute proportionally to the costs of implementing the union fisheries control system . ### member states shall require holders of a fishing licence for fishing vessels of 12 meters length overall or more flying their flag to contribute proportionally to the costs of implementing the union fisheries control system .


### although annexes to directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , and 2001 / 114 / ec contain technical elements which might have to be adapted or updated to take account of developments in relevant international standards , those directives do not confer on the commission appropriate powers to promptly adapt or update those annexes to take account of developments in international standards . in addition , directive 1999 / 4 / ec does not confer on the commission appropriate powers to promptly adapt or update its annex to take account of technical progress , although that annex contains technical elements which might also have to be adapted or updated to take account of technical progress . furthermore , although containing technical elements which might have to be adapted or updated to take account of technical progress , sections a and b of annex i to directive 2000 / 36 / ec are not covered by the commission ' s powers to adapt certain provisions of that annex to technical progress . therefore , for the consistent implementation of directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , 2001 / 113 / ec and 2001 / 114 / ec , the additional powers to adapt or update the annexes to directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , and 2001 / 114 / ec to take account of technical progress and of developments in international standards should also be conferred on the commission ### the annexes to directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , and 2001 / 114 / ec contain technical elements which might have to be adapted or updated in order to take account of developments in relevant international standards . where those provisions concern non - essential technical elements , namely in sections b , c and d of annex i to directive 2000 / 36 / ec , in section b of annex i to directive 2001 / 36 / ec and in section b of annex iii to directive 2001 / 113 / ec , it is appropriate to confer the power to adopt delegated acts on the commission in accordance with article 290 of the treaty , in order to bring those annexes into line with relevant developments in international standards or to take account of technical progress .


### the commission shall be empowered to adopt delegated acts in accordance with article 6 to amend the technical characteristics related to the sales names and definitions of section a of annex 1 , as well as sections b , c and d of that annex , to take account of the developments in relevant international standards , where appropriate , and of technical progress . ### the commission shall be empowered to adopt delegated acts in accordance with article 6 to amend sections c and d of annex i to take account of the developments in relevant international standards , where appropriate , and of technical progress .


### although annexes to directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , and 2001 / 114 / ec contain technical elements which might have to be adapted or updated to take account of developments in relevant international standards , those directives do not confer on the commission appropriate powers to promptly adapt or update those annexes to take account of developments in international standards . in addition , directive 1999 / 4 / ec does not confer on the commission appropriate powers to promptly adapt or update its annex to take account of technical progress , although that annex contains technical elements which might also have to be adapted or updated to take account of technical progress . furthermore , although containing technical elements which might have to be adapted or updated to take account of technical progress , sections a and b of annex i to directive 2000 / 36 / ec are not covered by the commission ' s powers to adapt certain provisions of that annex to technical progress . therefore , for the consistent implementation of directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , 2001 / 113 / ec and 2001 / 114 / ec , the additional powers to adapt or update the annexes to directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , and 2001 / 114 / ec to take account of technical progress and of developments in international standards should also be conferred on the commission ### annexes to directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , and 2001 / 114 / ec contain elements related to the product names and / or sales names , descriptions , definitions and characteristics of products which might have to be adapted or updated to take account of developments in relevant international standards or technical progress . where those provisions concern non - essential technical elements , namely in sections c and d of annex i to directive 2000 / 36 / ec , in part b of the annex to directive 2001 / 111 / ec and in part b of annex iii to directive 2001 / 113 / ec , it is appropriate to confer the power to adopt delegated acts on the commission in accordance with article 290 of the treaty , in order to bring those annexes into line with relevant developments in international standards or to take account of technical progress


### therefore , in order to supplement or amend certain non - essential elements of directives 1999 / 4 / ec , 2000 / 36 / ec , 2001 / 111 / ec , 2001 / 113 / ec and 2001 / 114 / ec to take account of technical progress and / or , where appropriate , the developments in international standards , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of the following scope and content : as regards directive 1999 / 4 / ec , to adapt or update the technical characteristics related to the product descriptions and definitions in the annex , normally expressed in percentages ; as regards directive 2000 / 36 / ec , to adapt or update the technical characteristics related to the sales names and definitions of section a of annex 1 , normally expressed in percentages and / or grams , as well as sections b , c and d of that annex ; as regards directive 2001 / 111 / ec , to adapt or update part a of the annex in respect of the technical characteristics related to the product names and definitions , as well as part b of the annex ; as regards directive 2001 / 113 / ec , to adapt or update annex i in respect of the technical characteristics related to the product names and definitions , normally expressed in grams and / or percentage , as well as annex ii and part b of annex iii ; and as regards directive 2001 / 114 / ec , to adapt or update annex i in respect of the technical characteristics related to the definitions of products and product names , normally expressed in percentages , as well as annex ii . ### therefore , in order to supplement or amend certain non - essential elements of directives 2000 / 36 / ec , 2001 / 111 / ec , 2001 / 113 / ec to take account of technical progress and / or , where appropriate , the developments in international standards , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of the following scope and content : as regards directive 2000 / 36 / ec , to adapt or update sections c and d of annex i ; as regards directive 2001 / 111 / ec , to adapt or update part b of the annex ; and as regards directive 2001 / 113 / ec , to adapt or update part b of annex iii .


### sustainable fisheries agreements with third countries shall establish a legal , economic and environmental governance framework for fishing activities carried out by union fishing vessels in third country waters . ### sustainable fisheries agreements with third countries shall establish a legal , economic , social and environmental governance framework for fishing activities carried out by union fishing vessels in third country waters . the agreements shall promote respect for human rights and contribute to sustainable development in third countries and to responsible fishing at global level .


### the commission shall ensure a midterm and final evaluation of the programme , regarding the aspects referred to in paragraph 2 and 3 . the results shall be integrated into decisions on possible renewal , modification or suspension of subsequent programmes . an independent external evaluator shall carry out these evaluations . ### the commission shall submit to the european parliament and to the council a midterm and final evaluation of the programme , regarding the aspects referred to in paragraph 2 and 3 . the results shall be integrated into decisions on possible renewal , modification or suspension of subsequent programmes . an independent external evaluator shall carry out these evaluations , based on a set of pre - defined indicators .


### to support the process of accession and association by third countries , the programme should be open for the participation of acceding and candidate countries as well as potential candidates and partner countries of the european neighbourhood policy if certain conditions are fulfilled . considering the increasing interconnectivity of the world economy , the programme continues to provide for the possibility to involve external experts , such as representatives of governmental authorities , economic operators and their oganisations or representatives of international organisations , in certain activities . ### to support the process of accession and association by third countries , not only should the programme be open for the participation of acceding and candidate countries as well as potential candidates and partner countries of the european neighbourhood policy if certain conditions are fulfilled , but the commission should also establish the conditions enabling accession to be brought about . considering the increasing interconnectivity of the world economy , the programme continues to provide for the possibility to involve external experts , such as representatives of governmental authorities , economic operators and their organisations or representatives of international organisations , in certain activities .


### to fight against tax fraud , tax evasion and tax avoidance , in particular by enhancing effective and efficient administrative cooperation and exchange of information ### to fight against tax fraud , tax evasion and tax avoidance and to protect the financial and economic interests of the union , the member states and union taxpayers , in particular by enhancing effective and efficient administrative cooperation and exchange of information ;


### the specific objective of the programme shall be to improve the operation of the taxation systems , in particular through cooperation between participating countries , their tax authorities , their officials and external experts . ### the specific objective of the programme shall be to improve the operation of the taxation systems , in particular through cooperation between participating countries , their tax authorities and their officials


### given the increasing globalisation , an efficient fight against fraud should equally have an international dimension . it is therefore useful to enable the union to conclude agreements on technical cooperation with developed third countries to allow those countries to use the union components of the european information systems to support a secureexchange of information between them and the member states in the framework of bilateral tax agreements . ### given the increasing globalisation , an efficient fight against tax fraud and tax evasion should equally have an international dimension . it is therefore useful to enable the union to conclude agreements on technical cooperation with developed third countries to allow those countries to use the union components of the european information systems to support a secure exchange of information between them and the member states in the framework of bilateral tax agreements .


### the programme objectives take into account the problems and challenges identified for taxation in the next decade . the programme should continue to play a role in vital areas like the coherent implementation of union law , administrative cooperation , the protection of the financial and economic interests of the union , enhancing the administrative capacity of tax authorities . given the problem dynamics of new challenges identified , additional emphasis should be put on fighting tax fraud , reduction of administrative burden and enhancing cooperation with third countries and parties . ### the programme objectives take into account the problems and challenges identified for taxation in the next decade . the programme should continue to play a role in vital areas like the coherent implementation of union law , administrative cooperation , the protection of the financial and economic interests of the union , enhancing the administrative capacity of tax authorities . given the problem dynamics of new challenges identified , additional emphasis should be put on fighting tax fraud and tax evasion , reduction of administrative burden and enhancing cooperation with third countries and parties .


### member states shall require issuers active in the extractive or logging of primary forest industries , as defined in [ … ] to prepare , in accordance with chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council , a report on payments made to governments on an annual basis . the report shall be made public at the latest six months after the end of each financial year and shall remain publicly available for at least five years . payments to governments shall be reported at consolidated level . ### member states shall require all issuers to prepare , as part of their annual financial statements , a report on payments made to governments in the countries in which they operate as if chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council applied . the report shall be made public at the latest six months after the end of each financial year and shall remain publicly available for at least five years . payments to governments shall be reported at consolidated level . the report should incorporate disclosures on a country - by - country basis . for issuers engaged in activities related to extractive or forest industries , disclosures should include types of payments comparable to those disclosed under the extractive industries transparency initiative and should be on a country - by - country and project - by - project basis , where a project means a contract , licence , lease or other legal agreement under which an issuer operates , and from which its specific revenue liabilities arise . for all issuers , disclosures should include turnover of the constituent entities of the undertaking that might give rise to payments and , on a per - country basis , quantities produced , profit before tax , effective tax rates , total number of people employed and their aggregate remuneration and expenditure on fixed asset investment during the course of the reporting period .


### the home member state may make an issuer subject to requirements more stringent than those laid down in this directive , except requiring issuers to publish periodic information other than annual financial reports referred to in article 4 and half - yearly financial reports referred to in article 5 . ### the home member state may make an issuer subject to requirements more stringent than those laid down in this directive .


### the home member state may make an issuer subject to requirements more stringent than those laid down in this directive , except requiring issuers to publish periodic information other than annual financial reports referred to in article 4 and half - yearly financial reports referred to in article 5 . ### the home member state may make an issuer subject to requirements more stringent than those laid down in this directive , except requiring small and medium - sized issuers to publish periodic information other than annual financial reports referred to in article 4 and half - yearly financial reports referred to in article 5 .


### in order to provide for enhanced transparency of payments made to governments , issuers whose securities are admitted to trading on a regulated market and which have activities in the extractive or logging of primary forest industries should disclose in a separate report on an annual basis payments made to governments in the countries in which they operate . the report should include types of payments comparable to those disclosed under the extractive industries transparency initiative and provide civil society with information to hold governments of resource - rich countries to account for their receipts from the exploitation of natural resources . the initiative is also complementary to the eu flegt action plan and the timber regulationwhich require traders of timber products to exercise due diligence in order to prevent illegal wood from entering into the eu market . the detailed requirements are defined in chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council . ### in order to provide for enhanced transparency of payments made to governments , issuers whose securities are admitted to trading on a regulated market should disclose as part of their annual financial statements payments made to governments in the countries in which they operate . disclosures should be made on a country - by - country basis . in the case of issuers engaged in activities related to extractive or forest industries , disclosures should include types of payments comparable to those disclosed under the extractive industries transparency initiative and should be on a country - by - country and project - by - project basis , where a project means a contract , licence , lease or other legal agreement under which an issuer operates and which gives rise to specific revenue liabilities . for all issuers , disclosures should include turnover of the constituent entities of the undertaking that might give rise to payments and , on a country - by - country basis , quantities produced , profit before tax , effective tax rates , total number of people employed and their aggregate remuneration and expenditure on fixed asset investment during the course of the reporting period . the detailed requirements are defined in chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council .


### the home member state may not make a holder of shares , or a natural person or legal entity referred to in articles 10 or 13 , subject to requirements more stringent than those laid down in this directive , except setting lower notification thresholds than those laid down in article 9 . ### the home member state may not make a holder of shares , or a natural person or legal entity referred to in articles 10 or 13 , subject to requirements more stringent than those laid down in this directive , except setting lower notification thresholds than those laid down in article 9 . the home member state shall ensure that issuers are not allowed to set additional notification thresholds in their articles of association .


### financial instruments that , on maturity , give the holder , under a formal agreement , either the unconditional right to acquire or the discretion as to his right to acquire , shares to which voting rights are attached , already issued , of an issuer whose shares are admitted to trading on a regulated market ; ### financial instruments that give the holder , under a formal agreement , either the unconditional right to acquire or the discretion as to his right to acquire , shares to which voting rights are attached , already issued , of an issuer whose shares are admitted to trading on a regulated market ;


### ‘ nanomaterial’ means nanomaterial as defined in commission recommendation 20 . . / … / ec of … … … concerning the definition of nanomaterials ; ### ‘ nanomaterial’ means nanomaterial as defined in commission recommendation 20 . . / … / ec of … … … concerning the definition of nanomaterials ; the commission shall regularly review and update the definition in light of latest advances in technical and scientific development .


### the evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly . in such cases , part of the fee paid in accordance with article 79 shall be reimbursed . ### the evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly . in such cases , part of the fees paid in accordance with article 79 and 79 shall be reimbursed .


### the active substance is essential to prevent or to control a serious danger to public or animal health or the environment ; or ### it is shown by evidence that the active substance is necessary to prevent or control a serious danger to public or animal health or to the environment , to food and feed safety , or to the public interest and that there are no effective alternative substances or technologies available . the use of any biocidal product containing active substances included in annex i pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised .


### for the purposes of this paragraph and for existing active substances listed in annex ii to regulation no 1451 / 2007 , the provisions on mandatory data sharing , as laid down in articles 61 and 62 of this regulation , shall apply to all toxicological and ecotoxicological studies included in the dossier . the relevant person shall be required to apply for data sharing only for those data that it does not already possess . ### for the purposes of this paragraph and for existing active substances listed in annex ii to regulation no . 1451 / 2007 , the provisions on data sharing , as laid down in articles 61 and 62 and 63 of this regulation , shall apply to all studies included in the dossier . the relevant person shall be required to apply for data sharing only for those data that it does not already possess .


### a list of all relevant data that it has generated since the initial authorisation or , as appropriate , previous renewal ; and ### without prejudice to article 20 , all relevant data required under article 19 that has been generated since the initial authorisation or , as appropriate , previous renewal , or a letter of access to these data ;


### 7 . 3 . by dermal route testing by the dermal route is appropriate if : – inhalation of the substance is unlikely ; or – skin contact in production and / or use is likely ; or – the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin . ### 7 . 3 . by dermal route testing by the dermal route is necessary only if : – inhalation of the substance is unlikely ; – skin contact in production and / or use is likely ; – the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin ; and – the results of an in vitro dermal penetration study demonstrate high dermal absorption and bioavailability .


### supplementary studies for combinations of biocidal products for biocidal products that are intended to be authorised for use with other biocidal products , the mixture of products , where possible , shall be tested for acute dermal toxicity and skin and eye irritation , as appropriate . ### supplementary studies for combinations of biocidal products for biocidal products that are intended to be authorised for use with other biocidal products , the risks to humans and the environment arising from the use of these product combinations shall be assessed . in some cases , for example where there is no valid data available of the kind set out in column 3 , this may require a limited number of acute toxicity studies to be carried using combinations of the products .


### the active substance is essential to prevent or to control a serious danger to public or animal health or the environment ; or ### it is shown by evidence that the active substance is necessary to prevent or control a serious danger to public or animal health or to the environment , to food and feed safety , or to the public interest and that there are no effective alternative substances or technologies available . the use of any biocidal product containing active substances included in annex i pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised . member state authorising a biocidal product containing an active substance included in annex i pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non - chemical methods , which are as effective as the biocidal product concerned and shall without delay transmit that plan to the commission . the use of the biocidal product with the active substance concerned shall be restricted to those member states where the serious danger has to be prevented or , if it occurs , controlled .


### applicants may apply for union authorisation for biocidal products which have similar conditions of use across the union and which fall within the following categories of biocidal products : biocidal products of product - types 6 , 7 , 9 , 10 , 12 , 13 and 22 ; and with effect from 1 january 2020 , all other biocidal products except for those of product types 14 , 15 , 17 , 20 and 21 . 2 . the commission shall report to the european parliament and the council on the application of this article by 31 december 2017 . it shall , if appropriate , accompany its report with relevant proposals for adoption in accordance with the ordinary legislative procedure . ### an application for union authorisation may be submitted for all categories of biocidal products with the exception of biocidal products that contain active substances that fall under article 5 .


### shall , in the case of data involving tests on vertebrate animals , request from the data owner the right to refer to those tests or studies ; and may , in the case of data not involving tests on vertebrate animals , request from the data owner the right to refer to those tests or studies . ### shall , in the case of data involving tests on vertebrate animals ; and may , in the case of data not involving tests on vertebrate animals , request from the data owner , all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications within the framework of this regulation .


### 7 . available toxicological data relating to : – co - formulants of concern ) , or – a mixture that a substance of concern is a component of – if no data is available , then the appropriate test described in annex ii , shall be carried out for the co - formulants of concern ) or a mixture that a substance of concern is a component of . ### 7 . available toxicological data relating to : – co - formulants of concern ) , or – a mixture that a substance of concern is a component of . if insufficient data are available for a co - formulant and cannot be inferred through read - across or other accepted non - testing approaches , targeted acute test described in annex ii , shall be carried out for the substance of concern or a mixture that a substance of concern is a component of .


### ' nanomaterial ' means nanomaterial as defined in commission recommendation 20 . . / … / ec of … … … concerning the definition of nanomaterials ; ### ' nanomaterial ' means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or is composed of discrete functional parts , either internally or at the surface , many of which have one or more dimensions of the order of 100 nm or less , including structures , agglomerates or aggregates , which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale . properties that are characteristic of the nanoscale include : those related to the large specific surface area of the materials considered ; and / or specific physico - chemical properties that are different from those of the non - nanoform of the same material . on entry into force of commission recommendation 20 . . / … / ec of … … concerning the definition of nanomaterials , this definition shall be replaced by the definition contained therein ;


### a biocidal product authorised in accordance with article&#160 ; 25 may be made available on the market in all member states without the need for mutual recognition . however , the authorisation holder shall notify each member state before placing the biocidal product on the market within the territory of that member state and shall use the official language or languages of that member state in the product ' s labelling , unless that member state provides otherwise . ### a biocidal product authorised in accordance with article&#160 ; 25 may be placed on the market in all member states without the need for mutual recognition . however , the authorisation holder shall notify each member state 30 days before placing the biocidal product on the market within the territory of that member state and shall use the official language or languages of that member state in the product ' s labelling , unless that member state provides otherwise .


### 10 . 2 . two - generation reproductive toxicity study , rat , oral route of administration is the preferred route . if another reproductive toxicity test is used justification shall be provided . ### 10 . 2 . two - generation reproductive toxicity study , rat , oral route of administration is the preferred route . if another reproductive toxicity test is used justification shall be provided . now that an extended one - generation reproductive toxicity study has been adopted at oecd level it should be considered as an alternative approach to the multi - generation study .


### the commission shall be empowered to adopt delegated acts in accordance with article 82 specifying scientific criteria for the determination of endocrine disrupting properties . ### no later than 13 december 2013 , the commission shall adopt delegated acts in accordance with article 82 specifying scientific criteria for the determination of endocrine disrupting properties .


### an active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point of article 18 taking into account the factors set out in article&#160 ; 18 and&#160 ; . ### an active substance shall be included in annex - i for an initial period not exceeding 10 years if at least one biocidal product containing that active substance fulfils the conditions laid down in point of article 18 taking into account the factors set out in article&#160 ; 18 and&#160 ; .


### the risk to humans or the environment from exposure to the active substance in a biocidal product , under realistic worst case conditions of use , is negligible , in particular where the product is used in closed systems or strictly controlled conditions ; ### the risk to humans or the environment from exposure to the active substance in a biocidal product , under realistic worst case conditions of use , is negligible , meaning that the product is used in closed systems or under other conditions excluding contact with humans ;


### the commission shall , on receipt of the opinion of the agency , adopt : an implementing regulation providing that the approval of an active substance is renewed for one or more product - types , and under which conditions ; or an implementing decision that the approval of an active substance is not renewed . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 81 . article 9 shall apply . ### the commission shall , on receipt of the opinion of the agency , adopt , by means of delegated acts in accordance with article 82 , a decision on the renewal of the inclusion of the active substance in annex - i for one or more product - types . in the event that the approval is renewed , the decision shall state the conditions of renewal .


### applicants may apply for union authorisation for biocidal products which have similar conditions of use across the union and which fall within the following categories of biocidal products : biocidal products of product - types 6 , 7 , 9 , 10 , 12 , 13 and 22 ; and with effect from 1 january 2020 , all other biocidal products except for those of product - types 14 , 15 , 17 , 20 and 21 . 2 . the commission shall report to the european parliament and the council on the application of this article by 31 december 2017 . it shall , if appropriate , accompany its report with relevant proposals for adoption in accordance with the ordinary legislative procedure . ### a union authorisation may be granted to all categories of biocidal products with the exception of biocidal products that contain active substances that fall under article 5 .


### within 90 days of validating the application , and subject to articles 34 , 35 and 36 , the member states concerned shall agree on the summary of biocidal product characteristics and shall record their agreement in the register for biocidal products . ### within 90 days of validating the application , and subject to articles 34 , 35 and 36 , the member states concerned shall agree on the summary of biocidal product characteristics included in the national authorisation granted by the reference member state and shall record their agreement in the register for biocidal products . without prejudice to articles 34 , 35 , and 36 , if agreement is not reached within the 90 day period referred to in the second subparagraph , each member state which agrees to the biocidal product characteristics referred to in the first subparagraph may register its agreement in the register of biocidal products and authorise the product in conformity with the summary of biocidal product characteristics to which it agreed .


### for the purposes of this paragraph and for existing active substances listed in annex ii to regulation no 1451 / 2007 , the provisions on mandatory data sharing , as laid down in articles 61 and 62 of this regulation , shall apply to all toxicological and ecotoxicological studies included in the dossier . the relevant person shall be required to apply for data sharing only for those data that it does not already possess . ### for the purposes of this paragraph and for existing active substances listed in annex ii to regulation no . 1451 / 2007 , the provisions on data sharing , as laid down in articles 61 , 62 , and 63 shall apply to all studies included in the dossier . the relevant person shall be required to apply for data sharing only for those data that it does not already possess and that involves tests on vertebrate animals only .