WELMEC Compliance of Imported -marked Prepackages

Transcription

1 WELMEC Cmpliance f Imprted -marked Prepackages

2 WELMEC is a cperatin between the legal metrlgy authrities f the Member States f the Eurpean Unin and EFTA. This dcument is ne f a number f Guides published by WELMEC t prvide guidance t packers, Imprters and the Cmpetent Departments respnsible fr ensuring the prepackages meet the specified requirements. The Guides are purely advisry and d nt themselves impse any restrictins r additinal technical requirements beynd thse cntained in relevant EU Directives. Alternative appraches may be acceptable, but the guidance prvided in this dcument represents the cnsidered view f WELMEC as t the best practice t be fllwed. Published by: WELMEC Secretariat secretary@welmec.rg Website: page 2 f 33

3 Frewrd WELMEC Wrking Grup 6 was set up t discuss, and prpse slutins fr, the prblems assciated with the trading f -marked prepacked prducts (herafter called prepackages ) between Member States. It was decided by the WELMEC Cmmittee 2 t prvide guidance fr Cmpetent Departments 3 and ecnmic peratrs t ensure that imprted prepackages cmply with legal requirements. This guide is t address all the issues fund in the imprted prepackages prject carried ut by WELMEC WG6 in 20. The intentin f this guide is t achieve a unifrm level f enfrcement and ensure that all prepackages, whether packed in, r imprted int, the Cmmunity (herafter called Unin 4 ) meet the applicable metrlgical requirements. This guide is part f a series f guides published by WELMEC, which are primarily intended t prvide guidance t all thse cncerned with the applicatin f Directive 76/2/EEC fr prepacked prducts. These guides are intended t lead t a unifrm interpretatin and enfrcement f this directive and assist in the remval f barriers t trade. Dcuments agreed by WELMEC are published n their website at Fr further infrmatin and advice n prepackages, please cntact yur natinal Cmpetent Department whse cntact details can be fund at Where in this guide the term Member State is used this means a cuntry f the Eurpean Ecnmic Area (EEA),Turkey r Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 2 WELMEC Cmmittee meeting May The Cmpetent Department is the term used in Directive 76/2/EEC fr a bdy that is respnsible fr ensuring that prepackages meet the legal requirements. It is fr each Member State t appint a Cmpetent Department. 4 The Unin shall mean the cuntries f the Eurpean Ecnmic Area (EEA), Turkey and Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. page 3 f 33

4 Cntents Intrductin Scpe Packer utside Eurpe Definitin Obligatins Ensuring cmpliance Persn arranging fr the packing t be dne Definitin Obligatins Ensuring cmpliance... 5 Distributer/Retailer Definitin Obligatins Ensuring cmpliance Imprter Definitin Examples Obligatins Ensuring cmpliance Agent f the Imprter Definitin Obligatins Ensuring cmpliance Cmpetent Department Definitin Obligatins Ensuring cmpliance Related Authrity Definitin Obligatins Ensuring cmpliance Certificatin Organisatin Definitin Obligatins Ensuring cmpliance page 4 f 33

5 Evidence prvider Definitin Obligatins Ensuring cmpliance Annex Labelling requirements fr prepackages Annex 2 Quantity requirements fr prepackages Annex 3 Cmpetent Departments prprtinate actins Annex 4 Related Authrity Infrmatin Exchange... 3 Annex 5 Evidence fr Imprters page 5 f 33

6 Intrductin. Directive 76/2/EEC (hereafter called the Directive ) states In the case f imprts frm nn-eec cuntries, the Imprter may instead f measuring and checking prvide evidence that he is in pssessin f all the necessary guarantees enabling him t assume respnsibility..2 The Eurpean Cmmissin has prvided its view n the applicatin f the Directive relating t imprts in One f the cnclusins was that guidance shuld be develped t reflect the specific situatin f Imprters 2..3 The Regulatin (EC) 765/2008 (hereafter called the Regulatin ) setting ut requirements fr accreditatin and market surveillance relating t the marketing f prducts 3 requires that market surveillance be applied where there are Unin harmnised requirements. It requires 4 that natinal market surveillance infrastructures and prgrammes shall ensure that effective measures can be taken in relatin t any prduct categry subject t Unin harmnised legislatin. This includes -marked prepackages (hereafter called prepackages ) and 3 -marked measuring cntainer bttles 5..4 The Regulatin als requires 6 that where in a Member State mre than ne authrity is respnsible fr market surveillance r external brder cntrls, thse authrities shall cperate with each ther, by sharing infrmatin relevant t their functins and therwise as apprpriate. In the light f this, this guide intends t give guidance t all relevant authrities. The cntact details f the Cmpetent Departments respnsible fr ensuring prepackages cmply with the requirements f the Directive are available n the WELMEC website 7..5 The respnsibilities specified in the Regulatin als include that authrities shall carry ut apprpriate checks n the characteristics f prducts n an adequate scale, in accrdance with the principles set ut in Article 9(), befre thse prducts are released fr free circulatin. This implies that t ensure there are n barriers t trade and t create a fair trading envirnment, all prepackages, whether imprted r packed in the Unin 8, shall 9 be subject t the same level f cmpliance checks. Directive 76/2/EEC, Annex I.4. 2 Reprt public cnsultatin: Metrlgical Requirements fr Prepackaged Prducts, 24 August 2005, paragraph 6. 3 Regulatin (EC) 765/2008, Chapter III cvers the market surveillance framewrk. 4 Regulatin (EC) 765/2008, Article 6, paragraph 3. 5 Directive 75/07/EEC, relating t bttles used as measuring cntainers. 6 Regulatin (EC) 765/2008, Article 27, paragraph The Unin shall mean the cuntries f the Eurpean Ecnmic Area (EEA), Turkey and Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 9 Regulatin (EC) 765/2008, Article 27, paragraph. page 6 f 33

7 2 Scpe 2. This guide aims t give guidance fr all authrities respnsible fr ensuring that prepackages that are released t the Unin 2 market meet the Eurpean legal metrlgy requirements. These authrities include but are nt limited t: - external brder cntrl, - Cmpetent Departments, and - authrities respnsible fr carrying ut market cntrl n prepackages This guide may als benefit thse rganisatins that: - intend t, r d imprt prepackages frm utside Eurpe (third cuntries) int Member States, - intend t, r d exprt prepackages t Eurpe, - intend t, r d distribute r sell imprted prepackages t ther distributrs, t retailers r t cnsumers, and - prvide evidence t Imprters abut prepackages and/r f packers utside Eurpe. Please nte that: - cmplying with this guide des nt preclude authrities t carry ut checks and surveillance activities in rder t ensure cmpliance with the Directive, and - ther legislatin may apply t prepackages imprted int the Unin that may cntain ther requirements that: are nt cvered by, and/r may be mre specific than the Directive. 2.3 This guide is structured s that there is a chapter fr each stakehlder utlining the legal bligatins and expectatins. The flwchart n the next page will direct stakehlders t the chapter relevant t their activity. Releasing t the market shall mean delivering t a Distributer/Retailer, t a Persn arranging fr the packing t be dne r t a cnsumer. 2 The Unin shall mean the cuntries f the Eurpean Ecnmic Area (EEA),Turkey and Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 3 See WELMEC Guide 6.7: Guidance fr Market Cntrl n Prepackages Fr Cmpetent Departments. page 7 f 33

8 Figure : Flwchart that directs stakehlders t the chapter relevant t their activity. page 8 f 33

9 3 Packer utside Eurpe 3. Definitin The Packer utside Eurpe means a packer lcated utside the Unin 2 and wh distributes prepackages: - t a Eurpean Imprter 3, r - t ne r mre Agents f the Imprter residing in ne r mre Member States 4, that bear a mark r inscriptin that identifies: - the Persn 5 arranging fr the packing t be dne 6, r - the Imprter established in a Member State. Nte : It is the Imprter wh is legally respnsible that the prepackages meet the requirements f the Directive, nt the Packer utside Eurpe. Nte 2: When the Packer utside Eurpe prvides results f measurements r f samples t the Eurpean Imprter, he may als be an Evidence prvider and chapter is als applicable. 3.2 Obligatins The Packer utside Eurpe shall: - ensure that the labelling requirements are met (see Annex ) and that the three quantity requirements are met (see Annex 2), - if the Imprter s requires, prvide adequate evidence t the Imprter s that the Imprter pssesses all the necessary guarantees enabling him t assume respnsibility. See Annex 5, - ensure that each batch is identifiable, and - if the Imprter assumes respnsibility based n evidence that the Packer utside Eurpe prvide, the relatinship between that evidence and the batch shall be related based n this batch identificatin. 3.3 Ensuring cmpliance T ensure cmpliance with the Directive, the Packer utside Eurpe shall prvide recrds t the Imprter f prepackages sld t him, in particular: - identificatin f batch(es), - cpy f the label, and - number f prepackages sld. A packer is a persn wh places prduct in packing material that bears a nminal quantity, an -mark and an identificatin f the Imprter r the Persn arranging fr the packing t be dne. 2 The Unin shall mean the cuntries f the Eurpean Ecnmic Area (EEA), Turkey and Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 3 See chapter 6: Imprter. 4 Member State means a cuntry f the Eurpean Ecnmic Area (EEA),Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 5 The term persn means any natural persn r any legal persn created and recgnised as such under natinal law, Eurpean Unin law r internatinal law, which has legal persnality and which may, acting in its wn name, exercise rights and be subject t bligatins. 6 See chapter 4: Persn arranging fr the packing t be dne. page 9 f 33

10 4 Persn arranging fr the packing t be dne 4. Definitin The Persn arranging fr the packing t be dne means a persn wh sells imprted prepackages that bear his name, mark r inscriptin that he btains frm an Imprter 2 r the Agent f the Imprter 3 and wh resides in ne r mre Member States 4. Nte : It is the Imprter wh is legally respnsible that the prepackages meet the requirements f the Directive, nt the Persn arranging fr the packing t be dne. The Persn arranging fr the packing t be dne is nly mentined in Annex I.3.2 f the Directive as ne f the three marks r inscriptins that shall appear n the label 5. In the first paragraph f Annex I.4 in the Directive nly the packer r Imprter have respnsibilities 6. The Persn arranging fr the packing t be dne is nt mentined anywhere else in the Directive and therefre has n respnsibilities in ensuring that prepackages meet the requirements f the Directive. Nte 2: Smene wh receives prepackages directly frm (the Packer) utside Eurpe, is either the Imprter f the Agent f the Imprter, even if the prepackages bear the name, mark r inscriptin f himself, r f the Packer utside Eurpe. Nte 3: This guide cvers prepackages imprted frm third cuntries 7 and therefre this chapter is nt applicable t a Persn arranging fr the packing t be dne wh btains prepackages that bear his name, mark r inscriptin frm a packer 8 that resides in a Member State. 4.2 Obligatins The Persn arranging fr the packing t be dne shall: - prvide t Cmpetent Departments 9 and Related Authrities 0, the name and address f the Imprter f the prepackages that he sells based n a specimen f the packing material f a single prepackage r n recrds, and - allw Cmpetent Departments t perfrm checks t ensure that the prepackages cmply with the prvisins f the Directive and fr the purpse f verifying that prepackages meet the requirements f the Directive. The term persn means any natural persn r any legal persn created and recgnised as such under natinal law, Eurpean Unin law r internatinal law, which has legal persnality and which may, acting in its wn name, exercise rights and be subject t bligatins. 2 See chapter 6: Imprter. 3 See chapter 7: Agent f the Imprter. 4 Member State means a cuntry f the Eurpean Ecnmic Area (EEA), Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 5 Directive 76/2/EEC, Annex I.3.2:. All prepackages made up in accrdance with this Directive shall bear n the package... a mark r inscriptin... t identify the packer r the Persn arranging fr the packing t be dne r the Imprter Directive 76/2/EEC, Annex I, 4: The packer imprter shall be respnsible fr ensuring that prepackages meet the requirements f this Directive. 7 A third cuntry is a cuntry that is nt a Member State. 8 A packer is a persn wh places prduct in packing material that bears a nminal quantity, an -mark and an identificatin f the Imprter r the Persn arranging fr the packing t be dne. 9 See chapter 8: Cmpetent Department. 0 See chapter 9: Related Authrity. As specified in Directive 76/2/EEC, Annex I.4 and I.5. page 0 f 33

11 4.3 Ensuring cmpliance T ensure cmpliance with the Directive, the Persn arranging fr the packing t be dne shall keep recrds f prepackages bught and sld, in particular: - number f prepackages bught and sld, - identificatin f batch(es), - cpy f the label, and - name and address f the Imprter r the Agent f the Imprter. page f 33

12 5 Distributer/Retailer 5. Definitin The Distributer/Retailer means a persn wh is part f the marketing prcess 2 f prepackages in the Unin 3, ther than the Imprter 4, an Imprters agent 5 r the Persn arranging fr the packing t be dne 6, wh buys prepackages frm an Imprter r whlesaler with the intentin f selling them t whlesalers and/r retailers and/r cnsumers. Nte : The Distributer/Retailer that sells prepackages that bear his name, mark r inscriptin is the Persn arranging fr the packing t be dne and chapter 4 applies. Nte 2: It is the Imprter wh is legally respnsible that the prepackages meet the requirements f the Directive, nt the Distributer/Retailer. 5.2 Obligatins The Distributr/retailer shall, based n recrds and/r a specimen f the packing material f a single prepackage, assist Cmpetent Departments 7 and Related Authrities 8 by prviding them with the: - name and address f the persn he btained the prepackages frm, - the name and address f the Imprter (if he has this infrmatin available), and - if he des nt sell t cnsumers, the name and address f the (legal) persn he has sld prepackages t. Furthermre, the Distributr/Retailer shall allw Cmpetent Departments t perfrm checks 9 t ensure that the prepackages cmply with the prvisins f the Directive and fr the purpse f verifying that prepackages meet the requirements f the Directive. 5.3 Ensuring cmpliance T ensure cmpliance with the Directive, the Distributr/Retailer shall keep recrds f prepackages bught and sld, in particular: - number f prepackages bught and sld, - identificatin f batch(es), - cpy f the label, - name and address f supplier, and - - in case f sale t ther distributer, whlesaler r retailer: name and address f whlesaler r retailer. The term persn means any natural persn r any legal persn created and recgnised as such under natinal law, Eurpean Unin law r internatinal law, which has legal persnality and which may, acting in its wn name, exercise rights and be subject t bligatins. 2 The term marketing prcess means the chain f distributin f prepackages starting with the Imprter and ending with sale t the cnsumer by the Retailer. 3 The Unin shall mean the cuntries f the Eurpean Ecnmic Area (EEA), Turkey and Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 4 See chapter 6: Imprter. 5 See chapter 7: Agent f the Imprter. 6 See chapter 4: Persn arranging fr the packing t be dne. 7 See chapter 8: Cmpetent Department. 8 See chapter 9: Related Authrity. 9 As specified in Directive 76/2/EEC, Annex I.4 and I.5. page 2 f 33

13 6 Imprter 6. Definitin The Imprter shall mean any persn 2 established within a Member State 3 wh releases 4 prepackages packed in a third cuntry 5 t the Unin 6 market. Nte : It is the Imprter wh is legally respnsible that the prepackages meet the requirements f the Directive. Nte 2: The Imprter is the persn wh decides whether prepackages meet the requirements, befre placing the prepackages n the market. The term decides includes (but is nt limited t): - written r ral instructin, rder r allwance t release t the market, - act f releasement t the market, - fail t prevent releasing t the market withut explicit decisin, and - subcntracting the releasement the market t an agent 7 (see nte 3). Nte 3: In the case that the Imprter relies n evidence that he is in pssessin f all the necessary guarantees enabling him t assume respnsibility, the Imprter may subcntract the releasing t the market t ne r mre f his agents that reside in ne r mre Member State(s). 6.2 Examples A fulfilment huse is deemed t be the Imprter, as he is nt the packer established in the Unin. A fulfilment huse may als be the Persn arranging fr the packing t be dne 8 in case his marks r inscriptins appear n the label. Derived frm Decisin Nr. 768/2008/EC, Article R.5. 2 The term persn means any natural persn r any legal persn created and recgnised as such under natinal law, Eurpean Unin law r internatinal law, which has legal persnality and which may, acting in its wn name, exercise rights and be subject t bligatins. 3 Member State means a cuntry f the Eurpean Ecnmic Area (EEA), Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 4 Releasing t the market shall mean delivering t a Distributer/Retailer, t a Persn arranging fr the packing t be dne r t a cnsumer. 5 A third cuntry is a cuntry that is nt a Member State. 6 The Unin shall mean the cuntries f the Eurpean Ecnmic Area (EEA), Turkey and Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 7 See chapter 7: Agent f the Imprter. 8 See chapter 4: Persn arranging fr the packing t be dne. page 3 f 33

14 6.3 Obligatins The Imprter shall either: a) carry ut checks n each batch f imprted prepackages in accrdance with prcedures recgnised by the Cmpetent Department f the Member State in which he is established 2, using a legal measuring instrument suitable fr effecting the necessary peratins t ensure that the prepackages meet all the labelling and quantity requirements. See Annexes and 2 and WELMEC Guide 6.4 3, b) decide whether the imprted prepackages meet the requirements based upn all the necessary guarantees enabling him t assume respnsibility fr each batch f prepackages imprted. This must be dne befre the prepackages are released t the market (see Annex 3), r c) a cmbinatin f bth a) and b). Furthermre, the Imprter shall: - prvide infrmatin regarding prepackages that will be imprted t the Cmpetent Department f the Member State he is established in as required by natinal prvisins. A minimum wuld be t ntify the Cmpetent Department f the Member State prir t the first imprtatin s that the Cmpetent Department is able t meet its bligatins and carry ut reference tests as required by the Directive n the Imprter s premises, - keep recrds f prepackages that have been imprted, bught and sld, - prvide assistance t Cmpetent Departments 4 and/r Related Authrities 5 f Member States where ne r mre f the Imprters Agents 6 are established in, and - allw Cmpetent Departments t perfrm checks 7 t ensure that the prepackages cmply with the prvisins f the Directive and fr the purpse f verifying that prepackages meet the requirements f the Directive. See chapter 8: Cmpetent Department. 2 If prvided fr by natinal legislatin. 3 WELMEC Guide 6.4: Guide fr Packers and Imprters f -marked prepacked prducts. 4 See chapter 8: Cmpetent Department. 5 See chapter 9: Related Authrity. 6 See chapter 7: Agent f the Imprter. 7 As specified in Directive 76/2/EEC, Annex I.4 and Annex I.5. page 4 f 33

15 6.4 Ensuring cmpliance T ensure cmpliance with the Directive, the Imprter shall have details f prepackages that will be imprted, in particular: - a cpy f the label, - descriptin f the prduct, - number f prepackages t be imprted, - the name and address f the packer in the third cuntry, - the identificatin f batch(es), and - the lcatin f batches f prepackages that will be imprted. This may include the lcatin f agents that reside in ne r mre Member State(s). Furthermre, the Imprter shall keep recrds f prepackages bught and sld, in particular: - thse cntaining: a) the results f the checks f 6.3a, in rder t certify that these checks have been prperly and accurately carried ut, and/r b) the evidence that the Imprter was in the pcessin f all the necessary guarantees enabling him t assume respnsibility fr each batch f imprted prepackages at the time f decisin-making as referred t in 6.3b (see Annex 5), - the decisin that the Imprter tk base in the abve recrds, - the lcatin f batches f prepackages that have been and will be imprted. This may include the lcatin f agents that reside in ne r mre Member State(s), - the number f prepackages bught and sld, - the identificatin f batch(es), - a cpy f the label, - the name and address f the packer in the third cuntry, and - in case f sale t anther distributer, whlesaler r retailer: name and address f distributer, whlesaler r retailer. page 5 f 33

16 7 Agent f the Imprter 7. Definitin The Agent f the Imprter shall mean any persn established within a Member State 2 wh releases 3 prepackages packed in a third cuntry 4 t the Unin 5 market under the respnsibility f an Imprter 6. Nte : It is the Imprter wh is legally respnsible that the prepackages meet the requirements f the Directive, nt the Agent f the Imprter. Nte 2: The Agent f the Imprter als becmes an Evidence prvider 7 if he carries ut sample checks frm batches f prepackages prduced by a packer in a third cuntry n behalf f the Imprter. Nte 3: It is the Imprter wh decides whether prepackages meet the requirements, befre he allws his Agent t release the prepackages t the market. 7.2 Obligatins The Agent f the Imprter shall: - prvide the name and address f the Imprter wh is respnsible fr the prepackages that the Agent f the Imprter releases t the Unin market t the Cmpetent Department 8 and Related Authrities 9 in the Member State where the Agent is established in, and - allw Cmpetent Departments t perfrm checks 0 t ensure that the prepackages cmply with the prvisins f the Directive and fr the purpse f verifying that prepackages meet the requirements f the Directive. The term persn means any natural persn r any legal persn created and recgnised as such under natinal law, Eurpean Unin law r internatinal law, which has legal persnality and which may, acting in its wn name, exercise rights and be subject t bligatins. 2 Member State means a cuntry f the Eurpean Ecnmic Area (EEA), Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 3 Releasing t the market shall mean delivering t a Distributer/Retailer, t a Persn arranging fr the packing t be dne r t a cnsumer. 4 A third cuntry is a cuntry that is nt a Member State. 5 The Unin shall mean the cuntries f the Eurpean Ecnmic Area (EEA), Turkey and Switzerland and any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 6 See chapter 6: Imprter. 7 See chapter 0: Evidence prvider. 8 See chapter 8: Cmpetent Department. 9 See chapter 9: Related Authrity. 0 As specified in Directive 76/2/EEC, Annex I.4 and Annex I.5. page 6 f 33

17 7.3 Ensuring cmpliance T ensure cmpliance with the Directive, the Agent f the Imprter shall keep recrds f prepackages received and delivered, in particular: - the lcatin f batches f prepackages that have been and will be received and delivered, - the number f prepackages received and delivered, - the identificatin f batch(es), - a cpy f the label, and - the name and address f the Imprter respnsible fr the prepackages. Furthermre, the Agent f the Imrter shall prvide infrmatin regarding prepackages that he will receive n behalf f the Imprter t the Cmpetent Department f the Member State he is established in as required by natinal prvisins. A minimum wuld be t ntify the Cmpetent Department f the Member State prir t the first time f receiving prepackages s that the Cmpetent Department is able t meet its bligatins and carry ut reference tests as required by the Directive n the Agent f the Imprters premises. page 7 f 33

18 8 Cmpetent Department 8. Definitin Cmpetent Department are the authrities respnsible fr ensuring 2 that Imprters meet the requirements f the Directive. Nte : There may be mre than ne Cmpetent Department in a Member State 3. Nte 2: The legal pwer f a Cmpetent Department is limited t the Member State in which the Cmpetent Department is lcated. Nte 3: (Parts f) the tasks f the Cmpetent Department may be carried ut by ther rganisatins under the respnsibility f the Cmpetent Department r whs respnsibility is laid dwn in legislatin. Nte 4: If prepackages arrive physicly at an Agent f the Imprter lcated in anther Member State than where the Imprter is lcated, it is the Cmpetent Department f the Member State where the Agent f the Imprter is lcated that is respnsible fr carrying ut the reference test. The nn-cmpliance shuld be referred back t the Cmpetent Department where the Imprter is lcated 4 wh will: a) acknwledge receipt f the referral, b) investigate the nn-cmpliance in a timely manner, c) give a prgress reprt every 4 weeks, and d) reprt back at the end the findings, and shuld a nn-cmpliance have been fund, cnfirm the crrective and preventative actin that has been taken tgether with the agreed timescale. An authrity is a public institutin with legal persnality, cmpnent f the State structure, n r belw the level f central gvernment and accuntable t citizens. 2 Recgnize prcedures (Directive 76/2/EEC, Annex I.4), carry ut the reference test n the packer's premises n the premises f the Imprter (Directive 76/2/EEC, Annex I.5) and carry ut ther checks (Directive 76/2/EEC, Annex.6). 3 Member State means a cuntry f the Eurpean Ecnmic Area (EEA), Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 4 See als WELMEC Guide 6.0: Intrductin t WELMEC dcuments n prepackages, chapter 2. page 8 f 33

19 8.2 Obligatins The Cmpetent Department recgnise the prcedures f Imprters 2 wh carry ut checks n each batch f imprted prepackages (as referred t in 6.3.a) and d nt assume their respnsibility based upn necessary guarantees enabling the Imprter t assume respnsibility (as referred t in 6.3.b). Furthermre, the Cmpetent Department perfrm checks n the premises f the Imprter r f his agent 3 t ensure that the prepackages cmply with the prvisins f the Directive 4 (reference test). The Cmpetent Department can carry ut any checks at any stage in the marketing prcess, in particular fr the purpse f verifying that prepackages meet the requirements f the Directive 5 (See WELMEC Guide ). 8.3 Ensuring cmpliance T ensure cmpliance with the Directive, the Cmpetent Department wrk with ther Cmpetent Departments and with Related Authrities 7 t: - share intelligence, and/r - plan and carry ut activities t ensure cmpliance with the requirements f the Directive. Furthermre, the Cmpetent Department respnd t infrmatin prvided t them by Cmpetent Departments in ther Member States, Related Authrities r cnsumers regarding prepackages in the marketplace and take apprpriate prprtinate actin t ensure cmpliance (see Annex 3). If prvided fr by natinal legislatin. 2 See chapter 6: Imprter. 3 See chapter 7: Agent f the Imprter. 4 As specified in Directive 76/2/EEC, Annex I.4. 5 As specified in Directive 76/2/EEC, Annex I.5. 6 WELMEC Guide 6.7: Guidance fr Market Cntrl n Prepackages Fr Cmpetent Departments. 7 See chapter 9: Related Authrity. page 9 f 33

20 9 Related Authrity 9. Definitin A Related Authrity is a public institutin with legal persnality, cmpnent f the State structure, n r belw the level f central gvernment and accuntable t citizens ther than the Cmpetent Department f a Member State 2 respnsible fr carrying ut enfrcement activities n its territry. Nte : (Parts f) the tasks f the Related Authrity may be carried ut by ther rganisatins under the respnsibility f that authrity. Nte 2: The activities are (but are nt limited t): custms, metrlgy, prduct safety, and fd safety. 9.2 Obligatins The Related Authrity shall wrk with Cmpetent Departments t: - share intelligence, and/r - plan and carry ut activities that facilitate Cmpetent Departments ensuring cmpliance with the requirements f the Directive. Furthermre, the Related Authrity shall enter int a frmal agreement with the Cmpetent Department as recmmended in Guidelines fr imprt cntrls in the area f prduct safety and cmpliance 3 prduced by the Eurpean Cmmissin fr Custms. 9.3 Ensuring cmpliance T ensure cmpliance with the Directive, the Related Authrity shall pass n t the Cmpetent Department a cpy f the label frm a prepackage which bears an -mark. Furthermre, the Related Authrity shall pass n t the Cmpetent Department, in particular, cpy f any nn-cmpliant labelling, including any batch cde and details f Imprter and the strage (warehuse) facilities where prepackages can be inspected and tested. Nn-cmpliant labelling includes: a) the wrng shaped, b) being less than 3 mm high, c) quantity declaratin being t small, and d) illegal symbls fr weight and vlume, that is any that are nt g, kg, ml, ml, cl, cl, l and L. See Annex fr the requirements. See Annex 4 fr a flw chart fr prprtinate actins. See chapter 8: Cmpetent Department. 2 Member State means a cuntry f the Eurpean Ecnmic Area (EEA), Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 3 page 20 f 33

21 0 Certificatin Organisatin 0. Definitin A Certificatin Organisatin is a persn wh assesses the prcedures that a Packer utside Eurpe 2 uses: - t ensure that the prepackages meet the requirements at the mment f imprtatin in ne r mre Member States 3, and - that make up the evidence that enables the Imprter 4 t assume respnsibility. Nte : Cmpetent Departments 5 qualify as Certificatin Organisatins. Other rganisatins that carriy ut relevant (parts f the) tasks f the Cmpetent Department under the respnsibility f the Cmpetent Department r whs respnsibility is laid dwn in legislatin 6, als qualify as a Certificatin Organisatin. Nte 2: Anther persn qualifies as a Certificatin Organisatin after it has been established that the persn is independent, credible and capable, where: established means an investigatin by a Cmpetent Department f the Member State where the Imprter is lcated that cvers independence, credibility and capability, where a descisin made by anther Cmpetent Department can be taken int accunt, if available, an independent persn is disinterested frm the Packer utside Eurpe, the Imprter, the Agent f the Imprter 7, the Distributer/Retailer 8 and the Persn arranging fr the packing t be dne 9, a credible persn is: accredited by an accreditatin bdy in a Member State against ISO 702 r an equivalent standard, r peer-t-peer assessed by a Cmpetent Department in a Member State against ISO 702 r an equivalent standard and f which the descisin has been made available t Cmpetent Departments in ther Member States, a capable persn judges filling and measuring/checking prcedures f a sufficient number f packers as r n behalf f a gvernmental authrity against criteria laid dwn in chapter 4 f WELMEC Guide r equivalent. The term persn means any natural persn r any legal persn created and recgnised as such under natinal law, Eurpean Unin law r internatinal law, which has legal persnality and which may, acting in its wn name, exercise rights and be subject t bligatins. 2 See chapter 3: Packer utside Eurpe. 3 Member State means a cuntry f the Eurpean Ecnmic Area (EEA), Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 4 See chapter 6: Imprter. 5 See chapter 8: Cmpetent Department. 6 See chapter 8: Cmpetent Department, nte 3. 7 See chapter 7: Agent f the Imprter. 8 See chapter 5: Distributer/Retailer. 9 See chapter 4: Persn arranging fr the packing t be dne. 0 WELMEC Guide 6.6: Guide fr recgnitin f prcedures. page 2 f 33

22 0.2 Obligatins The Certificatin Organisatin shall perfrm audits and surveillance in accrdance with the requirements f ISO 702 r an equivalent standard. Furthermre, the Certificatin Organistain shall describe the packer s prcedures cvering the subjects f chapter 4 f WELMEC Guide Ensuring cmpliance T ensure cmpliance with the Directive, the Certificatin Organisatin shall prvide t the Imprter: - a descriptin f the packer s prcedures cvering the subjects f chapter 4 f WELMEC Guide 6.6, - reprts f audits and surveillances f the prcedures f packers utside Eurpe, and - a cpy f accreditatin certificate, including scpe, standard and date f validity r f evidence f peer-t-peer assessments by a Cmpetent Department in a Member State. WELMEC Guide 6.6: Guide fr recgnitin f prcedures. page 22 f 33

23 Evidence prvider. Definitin An Evidence prvider is any persn that n behalf f the Imprter 2 carries ut measurements r checks n batches f prepackages filled by a Packer utside Eurpe 3 that enable the Imprter t assume his respnsibility (see chapter 6.3b). Nte : It is the Imprter wh is legally respnsible that the prepackages meet the requirements f the Directive, nt the Evidence prvider. Nte 2: An Evidence prvider can be: a) a persn f which a Cmpetent Department f the Member State, where the Imprter is lcated, has established that the persn is independent, credible and capable, where: - established means an investigatin by a Cmpetent Department f the Member State where the Imprter is lcated that cvers independence, credibility and capability and f which the descisin has been made available t Cmpetent Departments in ther Member States, - an independent persn is disinterested frm the Packer utside Eurpe, the Imprter, the Agent f the Imprter 4, the Distributer/Retailer 5 and the Persn arranging fr the packing t be dne 6, - a credible persn is: accredited by an accreditatin bdy in a Member State 7 against ISO 7020, ISO 7025 r an equivalent standard, r peer-t-peer assessed by a Cmpetent Department 8 in a Member State and f which the results have been made available fr Cmpetent Departments in ther Member States - a capable persn: has inspectin f prepackages r testing f prepackages in its scpe, r perfrms a significant number f reference tests f prepackages as a gvernmental authrity. b) The packer in a third cuntry 9, in which case his prcedures have t be assessed by a Certificatin Organisatin 0. c) The Agent f the Imprter. The results f checks by the Agent f the Imprter are a sufficient guarantee that enable the Imprter t assume his respnsibility (see chapter 6.3b) if these checks are carried ut in accrdance with prcedures recgnised by the Cmpetent Department f the Member State where the Agent f the Imprter is established. The term persn means any natural persn r any legal persn created and recgnised as such under natinal law, Eurpean Unin law r internatinal law, which has legal persnality and which may, acting in its wn name, exercise rights and be subject t bligatins. 2 See chapter 6: Imprter. 3 See chapter 3: Packer utside Eurpe. 4 See chapter 7: Agent f the Imprter. 5 See chapter 5: Distributer/Retailer. 6 See chapter 4: Persn arranging fr the packing t be dne. 7 Member State means a cuntry f the Eurpean Ecnmic Area (EEA), Turkey r Switzerland r any ther cuntry that the EU has a frmal agreement with that cvers prepackages. 8 See chapter 8: Cmpetent Department. 9 A third cuntry is a cuntry that is nt a Member State. 0 See chapter 0: Certificatin Organisatin. page 23 f 33

24 .2 Obligatins The Evidence prvider shall carry ut checks n prepackages that enable the Imprter t assume his respnsibility. Furthermre, the Evidence prvider shall prve the (cntinued) ability t perfrm such checks..3 Ensuring cmpliance T ensure cmpliance with the Directive, the Evidence prvider shall prvide the Imprter with the results f measurements r checks. See Annex A.5.. Furthermre, the Evidence prvider shall prvide the Imprter with a prf f credibility. See Annex A.5.2. page 24 f 33

25 Annex Labelling requirements fr prepackages A.. The -mark The -mark shall be a minimum f 3 mm high, placed in the same field f visin as the indicatin f the nminal quantity, and be f the frm as shwn belw. A..2 Nminal quantity The nminal quantity (nminal weight r vlume) shall be expressed in the SI units f kilgrams, grams, litres, centilitres r millilitres. If the unit f measurement is nt spelt ut in full, then the nly permissible symbls are: - kg r g, and - l, L, cl, cl, ml r ml. The nminal quantity must be in figures, nt written ut in text. Example: kg is acceptable but ne kg is nt acceptable. Apprximate indicatins like ca. 200 g are nt allwed. The figures must be at least the fllwing minimum heights: Nminal quantity g r ml Minimum heights f figures mm 5 < Q n < Q n < Q n < Q n Markings in imperial (UK and US) units shall be in letters and figures f dimensins nt larger than thse f the crrespnding markings in SI units. page 25 f 33

26 A..3 Identity f the Persn arranging fr the packing t be dne r the Imprter A mark r inscriptin enabling the Cmpetent Departments t identify : a) the Persn arranging fr the packing t be dne, r b) the Imprter established in the Unin. The identity markings n the prepackage shall identify a Persn arranging fr the packing t be dne (fr whm the prepackages have been imprted r packed fr) r the Imprter. Where the markings n prepackages d nt identify the Imprter in a Member State, it is the respnsibility f the persn whse name and address r mark appears n the prepackage t identify the Imprter in a Member State t the Cmpetent Department. On 27 Nvember 203 Daniel Hanekuyk prvided the pinin f the DG-ENTR lawyer n whether the persn identified n the label f a prepackage must reside in the EEA, Switzerland r Turkey: "at least ne name and address r mark f the Packer, the Persn arranging the packing t be dne r the Imprter established in the EU must appear. Addresses referring t Packers utside EU have n legal relevance. The persn identified, and their address, shall be within a Member State. page 26 f 33

27 Annex 2 Quantity requirements fr prepackages Prepackages cvered by the Directive shall be made up in such a way that batches f cmpleted prepackages satisfy the fllwing requirements. A.2. Average actual quantity the actual cntents shall nt be less, n average, than the nminal quantity 2 The prepackages shall pass the reference test f the Directive r a test whse effectiveness is cmparable t that reference test. The reference test shall be carried ut by the Cmpetent Department and shall be perfrmed n a sample drawn frm a batch f imprted prepackages which cnsist f up t prepackages. A.2.2 TU-limit the prprtin f prepackages having a negative errr greater than the tlerable negative errr laid dwn shall be sufficiently small fr batches f prepackages t satisfy the requirements f the tests specified in Annex II. 3 The tlerable negative errr (TNE) fr each nminal quantity is specified in paragraph 2.4 f Annex I f the Directive. The quantity, which is ne tlerable negative errr belw the nminal quantity, is smetimes referred t as TU r T. A defective prepackage is ne whse quantity f prduct is belw TU r T. Sufficiently small is nt defined in the Directive althugh the reference test is based n an AQL (acceptable quality level) f 2.5%. Because statistical methds f testing are used, there is still a risk f failing a batch even if the amunt f TU is less than 2.5%. A.2.3 TU2-limit n package having a negative errr greater than twice the tlerable negative errr given in the table in 2.4 may bear the EEC sign 4 The quantity which is tw tlerable negative errrs belw the nminal quantity is smetimes referred t as TU2 r T2. A.2.4 Other checks The Cmpetent Departments can carry ut any checks at any stage in the marketing prcess, in particular fr the purpse f verifying that prepackages meet the requirements f the Directive. A batch shall cmprise all the prepackages f the same nminal quantity, the same type and the same prductin run, packed in the same place. 2 Directive 76/2/EEC, Annex I.,.. 3 Directive 76/2/EEC, Annex I.,.2. 4 Directive 76/2/EEC, Annex I.,.3. page 27 f 33

28 Annex 3 Cmpetent Departments prprtinate actins Cmpetent Departments have the respnsibility t ensure cmpliance f all -marked prepackages, and this needs t be effectively and efficiently. The flw charts in this annex prvide a methd f risk-based actins t carry ut their bligatins. A.3. Market Cntrl Where prepackages frm an unknwn surce are fund anywhere in the marketplace, and it is pssible t carry ut quantity checks n the prepackages, the fllwing screen test will ensure cnsistency f enfrcement using a risked-based apprach. A.3.2 Actin based n infrmatin Where a Cmpetent Department receives infrmatin regarding imprted prepackages frm anther Cmpetent Department r a Related Authrity, the fllwing prvides guidance n prprtinate actins t take. Where the Related Authrity infrms the Cmpetent Department f prepackages with nncmpliant labels, the Cmpetent Department has the respnsibility f ensuring nncmpliant prepackages are nt released t the marketplace. The Cmpetent Department needs t decide n whether t release the batch based n bjective evidence. page 28 f 33

29 One avenue is fr the Cmpetent Department t carry ut a reference test n the impunded batch f prepackages. Where the Cmpetent Department receives infrmatin f imprted prepackages which are crrectly labelled, the fllwing flwchart will ensure cnsistency f enfrcement using a risked-based apprach. page 29 f 33

30 Appendix Imprted Prepackages Questinnaire Name & address f persn: Prduct name & quantity: Batch identity: (insert) Imprted n: (date). Are yu the persn wh imprted the prepackages int the EEA? YES / NO If NO, what are the cntact details f the Imprter? 2. If YES, what is the address f the warehuse: 3. Hw d yu fulfil yur legal metrlgy respnsibilities? a) Carry ut physical quantity checks n batches YES / NO b) Rely n dcumentatin YES / NO 4. If dcumentatin, which f the fllwing is used: a) Actual prductin quantity cntrl recrds YES / NO b) Declaratin that is packing t a minimum YES / NO c) A statement frm the metrlgy service YES / NO d) Other, please state.. 5. Please send cpy f the dcuments (check results r dcumentatin) relating t the imprt f the batch f prduct identified abve. Nte: The guarantees and the dcuments used by the Imprter t ensure his respnsibility need t be understandable by the Cmpetent Department. Thank yu fr yur time in cmpleting the abve, please pst r back t sender. page 30 f 33

31 Annex 4 Related Authrity Infrmatin Exchange Fllwing the flw chart belw will effectively and efficiently mnitr the imprtatin f prepackages. page 3 f 33

32 Annex 5 Evidence fr Imprters Evidence that enable the Imprter t assume his respnsibility cnsists f: - the results f measurements r checks (see A.5.), and - prf f credibility f the persn wh perfrmed the checks (see A.5.2). In any case it is the Imprter that decides whether each batch f imprted prepackages meet the requirements f the Directive based upn the abve evidence. This must be dne befre the prepackages are released t the market. A.5. Results f measurements r checks The results f measurements r checks cnsist f: - batch size, batch identificatin, cpy r pht f label, - infrmatin f accuracy f measuring equipment used: pht f dataplate(s), - cllectin f measuring results: packing material: sample size, 00% (in case f individual tare) r nne (in case f net-weighing), density (in case f declaratin in unit f vlume), and prepackages: sample size r 00% (in case f use f checkweigher/multihead), - measuring results: weight f packing material, density f prduct (in case f declaratin in unit f vlume), and prepackages: in case f sampling: individual results, average and standard deviatin, and in case f checkweigher/multihead: average and standard deviatin, - calculatins perfrmed with measuring results (frmulae), - acceptance and rejectin criteria fr: average quantity f prduct f prepackages in the batch, number and/r percentage f prepackages with actual quantity f prduct less than TU, and number f prepackages with actual quantity f prduct less than TU2. The prcedures f a Packer utside Eurpe that cmply with the requirements f chapter 4 f WELMEC Guide 6.6 prvide fr the abve evidence. WELMEC Guide 6.6: Guide fr recgnitin f prcedures. page 32 f 33

33 A.5.2 Prf f credibility f the persn wh perfrmed the checks The prf f credibility that the Imprter must use depends n the persn that prvided the evidence fr: A.5.2. Checks by an independent, credible and qualified bdy A cpy f: - the accreditatin certificate, including scpe, standard and date f validity, r - results f peer-t-peer assessments by a Cmpetent Department in a Member State. A Checks by the packer in the third cuntry - a descriptin f the packer s prcedures cvering the subjects f chapter 4 f WELMEC Guide 6.6, and - reprts f initial audits and yearly surveillances by the Certificatin Organisatin f the prcedures f the Packer utside Eurpe, and - a cpy f: the accreditatin certificate f the Certificatin Organisatin, including scpe, standard and date f validity, r evidence f peer-t-peer assessments by a Cmpetent Department in a Member State f the Certificatin Organisatin, including scpe, standard and date f validity. A Checks by the Agent f the Imprter - a descriptin f the prcedures f the packer in the third cuntry cvering the subjects f chapter 4 in WELMEC Guide 6.6, and - evidence that these prcedures have been recgnised by the Cmpetent Department in the Member State where the agent is lcated in. WELMEC Guide 6.6: Guide fr recgnitin f prcedures. page 33 f 33